Trial Outcomes & Findings for Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma (NCT NCT00057811)

NCT ID: NCT00057811

Last Updated: 2014-09-19

Results Overview

The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 97 participants
• Primary outcome timeframe: Up to 1 year
• Results posted on: 2014-09-19

Participant Flow

Participant milestones

Measure	Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.	Group C (Chemotherapy, Monoclonal Antibody Therapy) Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
Overall Study STARTED	51	46
Overall Study COMPLETED	41	34
Overall Study NOT COMPLETED	10	12

Reasons for withdrawal

Measure	Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.	Group C (Chemotherapy, Monoclonal Antibody Therapy) Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
Overall Study Lack of Efficacy	1	4
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	3	4
Overall Study Ineligible	4	2
Overall Study Inevaluable	1	2

Baseline Characteristics

Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma

Baseline characteristics by cohort

Measure	Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) n=51 Participants Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.	Group C (Chemotherapy, Monoclonal Antibody Therapy) n=46 Participants Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.	Total n=97 Participants Total of all reporting groups
Age, Categorical <=18 years	49 Participants n=5 Participants	44 Participants n=7 Participants	93 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	4575 days n=5 Participants	3132 days n=7 Participants	3853.5 days n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	37 Participants n=7 Participants	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	36 Participants n=7 Participants	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants	34 Participants n=7 Participants	74 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants	38 participants n=7 Participants	85 participants n=5 Participants
Region of Enrollment Australia	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Canada	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.

The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences

Outcome measures

Measure	Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) n=45 Participants Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.	Group C (Chemotherapy, Monoclonal Antibody Therapy) n=40 Participants Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
Grade ≥ 3 Stomatitis Incidence of grade ≥ 3 stomatitis	4 participants	6 participants
Grade ≥ 3 Stomatitis No incidence of grade ≥ 3 stomatitis	41 participants	34 participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: Population analyzed includes eligible patients considered evaluable for response (with measurable disease at on study and adequate assessment of response).

Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present..

Outcome measures

Measure	Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) n=32 Participants Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.	Group C (Chemotherapy, Monoclonal Antibody Therapy) n=23 Participants Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
Response Rate	88 percentage of participants analyzed Interval 71.0 to 96.0	83 percentage of participants analyzed Interval 61.0 to 95.0

PRIMARY outcome

Timeframe: Not Provided

Population: Population analyzed included patients submitting samples for minimal disease assay at end induction

The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow. Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section).

Outcome measures

Measure	Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) n=32 Participants Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.	Group C (Chemotherapy, Monoclonal Antibody Therapy) n=10 Participants Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
Minimal Residual Disease	22 percentage of samples analyzed Interval 11.0 to 40.0	70 percentage of samples analyzed Interval 35.0 to 93.0

PRIMARY outcome

Timeframe: Up to 1 year

Population: Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.

Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death.

Outcome measures

Measure	Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) n=45 Participants Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.	Group C (Chemotherapy, Monoclonal Antibody Therapy) n=40 Participants Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
Toxic Death Toxic death	0 participants	2 participants
Toxic Death No toxic death	45 participants	38 participants

Adverse Events

Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Group C (Chemotherapy, Monoclonal Antibody Therapy)

Serious events: 6 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) n=46 participants at risk Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.	Group C (Chemotherapy, Monoclonal Antibody Therapy) n=42 participants at risk Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
Blood and lymphatic system disorders Anemia	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Blood and lymphatic system disorders Febrile neutropenia	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Cardiac disorders Sinus tachycardia	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Eye disorders Photophobia	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Abdominal pain	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Colitis	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Esophageal pain	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Esophagitis	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Mucositis oral	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	14.3% 6/42 • Number of events 6 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Nausea	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Oral pain	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Typhlitis	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Immune system disorders Anaphylaxis	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Infections and infestations Enterocolitis infectious	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Infections and infestations Lung infection	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Alanine aminotransferase increased	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Aspartate aminotransferase increased	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Blood bilirubin increased	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Creatinine increased	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Neutrophil count decreased	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Platelet count decreased	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Weight loss	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations White blood cell decreased	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Acidosis	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Anorexia	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Dehydration	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hypokalemia	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Tumor lysis syndrome	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Nervous system disorders Dizziness	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Nervous system disorders Headache	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Nervous system disorders Seizure	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Renal and urinary disorders Acute kidney injury	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Renal and urinary disorders Cystitis noninfective	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Renal and urinary disorders Urinary frequency	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Vascular disorders Hypertension	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Vascular disorders Hypotension	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.

Other adverse events

Measure	Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) n=46 participants at risk Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.	Group C (Chemotherapy, Monoclonal Antibody Therapy) n=42 participants at risk Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Blood and lymphatic system disorders Anemia	69.6% 32/46 • Number of events 32 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	76.2% 32/42 • Number of events 32 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Blood and lymphatic system disorders Bone marrow hypocellular	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Blood and lymphatic system disorders Febrile neutropenia	39.1% 18/46 • Number of events 18 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	52.4% 22/42 • Number of events 22 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Cardiac disorders Asystole	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Cardiac disorders Cardiac disorders - Other, specify	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Cardiac disorders Mobitz type I	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Cardiac disorders Sinus bradycardia	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Cardiac disorders Sinus tachycardia	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Ear and labyrinth disorders External ear inflammation	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Ear and labyrinth disorders Hearing impaired	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Eye disorders Blurred vision	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Eye disorders Conjunctivitis	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Eye disorders Dry eye	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Eye disorders Extraocular muscle paresis	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Eye disorders Eye disorders - Other, specify	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Eye disorders Eye pain	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Eye disorders Photophobia	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Abdominal distension	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Abdominal pain	17.4% 8/46 • Number of events 8 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	26.2% 11/42 • Number of events 11 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Anal mucositis	6.5% 3/46 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Colitis	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Constipation	10.9% 5/46 • Number of events 5 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	14.3% 6/42 • Number of events 6 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Diarrhea	13.0% 6/46 • Number of events 6 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	31.0% 13/42 • Number of events 13 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Dry mouth	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Dyspepsia	6.5% 3/46 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Dysphagia	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Esophageal pain	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Esophagitis	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Gastric hemorrhage	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Gastritis	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Gingival pain	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Hemorrhoids	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Ileus	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Mucositis oral	41.3% 19/46 • Number of events 19 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	42.9% 18/42 • Number of events 18 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Nausea	21.7% 10/46 • Number of events 10 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	35.7% 15/42 • Number of events 15 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Oral hemorrhage	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Oral pain	6.5% 3/46 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	16.7% 7/42 • Number of events 7 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Rectal hemorrhage	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Rectal mucositis	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Rectal pain	6.5% 3/46 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Stomach pain	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Gastrointestinal disorders Vomiting	17.4% 8/46 • Number of events 8 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	31.0% 13/42 • Number of events 13 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
General disorders Chills	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
General disorders Edema limbs	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	9.5% 4/42 • Number of events 4 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
General disorders Fatigue	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	16.7% 7/42 • Number of events 7 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
General disorders Fever	8.7% 4/46 • Number of events 4 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	26.2% 11/42 • Number of events 11 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
General disorders Flu like symptoms	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
General disorders Gait disturbance	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
General disorders General disorders and administration site conditions - Other, specify	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
General disorders Pain	15.2% 7/46 • Number of events 7 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	11.9% 5/42 • Number of events 5 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hypocalcemia	34.8% 16/46 • Number of events 16 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	47.6% 20/42 • Number of events 20 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Hepatobiliary disorders Hepatic pain	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Immune system disorders Allergic reaction	10.9% 5/46 • Number of events 5 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Immune system disorders Anaphylaxis	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Infections and infestations Catheter related infection	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	11.9% 5/42 • Number of events 5 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Infections and infestations Enterocolitis infectious	10.9% 5/46 • Number of events 5 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Infections and infestations Infections and infestations - Other, specify	34.8% 16/46 • Number of events 16 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	54.8% 23/42 • Number of events 23 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Infections and infestations Lip infection	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Infections and infestations Lung infection	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Infections and infestations Mucosal infection	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Infections and infestations Otitis externa	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Infections and infestations Otitis media	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Infections and infestations Pharyngitis	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Infections and infestations Sinusitis	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Infections and infestations Skin infection	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Infections and infestations Small intestine infection	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Infections and infestations Tooth infection	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Infections and infestations Urinary tract infection	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Injury, poisoning and procedural complications Bruising	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Injury, poisoning and procedural complications Fracture	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Injury, poisoning and procedural complications Vascular access complication	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Injury, poisoning and procedural complications Venous injury	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Activated partial thromboplastin time prolonged	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Alanine aminotransferase increased	58.7% 27/46 • Number of events 27 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	59.5% 25/42 • Number of events 25 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Alkaline phosphatase increased	10.9% 5/46 • Number of events 5 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Aspartate aminotransferase increased	34.8% 16/46 • Number of events 16 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	50.0% 21/42 • Number of events 21 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Blood bilirubin increased	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	31.0% 13/42 • Number of events 13 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations CD4 lymphocytes decreased	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Cholesterol high	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Creatinine increased	13.0% 6/46 • Number of events 6 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	19.0% 8/42 • Number of events 8 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Fibrinogen decreased	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations GGT increased	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	19.0% 8/42 • Number of events 8 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations INR increased	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Investigations - Other, specify	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	11.9% 5/42 • Number of events 5 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Lipase increased	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Lymphocyte count decreased	19.6% 9/46 • Number of events 9 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	21.4% 9/42 • Number of events 9 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Neutrophil count decreased	67.4% 31/46 • Number of events 31 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	83.3% 35/42 • Number of events 35 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Platelet count decreased	63.0% 29/46 • Number of events 29 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	81.0% 34/42 • Number of events 34 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Serum amylase increased	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Weight gain	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations Weight loss	6.5% 3/46 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	14.3% 6/42 • Number of events 6 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Investigations White blood cell decreased	67.4% 31/46 • Number of events 31 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	69.0% 29/42 • Number of events 29 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Acidosis	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Alkalosis	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Anorexia	6.5% 3/46 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	28.6% 12/42 • Number of events 12 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Dehydration	6.5% 3/46 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	11.9% 5/42 • Number of events 5 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hypercalcemia	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	11.9% 5/42 • Number of events 5 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hyperglycemia	43.5% 20/46 • Number of events 20 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	42.9% 18/42 • Number of events 18 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hyperkalemia	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hypermagnesemia	8.7% 4/46 • Number of events 4 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hypernatremia	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	9.5% 4/42 • Number of events 4 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hypertriglyceridemia	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hyperuricemia	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hypoalbuminemia	28.3% 13/46 • Number of events 13 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	42.9% 18/42 • Number of events 18 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hypoglycemia	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hypokalemia	37.0% 17/46 • Number of events 17 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	54.8% 23/42 • Number of events 23 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hypomagnesemia	21.7% 10/46 • Number of events 10 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	21.4% 9/42 • Number of events 9 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hyponatremia	34.8% 16/46 • Number of events 16 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	38.1% 16/42 • Number of events 16 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Hypophosphatemia	30.4% 14/46 • Number of events 14 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	26.2% 11/42 • Number of events 11 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Metabolism and nutrition disorders Tumor lysis syndrome	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	9.5% 4/42 • Number of events 4 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Musculoskeletal and connective tissue disorders Back pain	10.9% 5/46 • Number of events 5 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	11.9% 5/42 • Number of events 5 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Musculoskeletal and connective tissue disorders Bone pain	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Musculoskeletal and connective tissue disorders Buttock pain	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Musculoskeletal and connective tissue disorders Myalgia	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Musculoskeletal and connective tissue disorders Neck pain	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Musculoskeletal and connective tissue disorders Pain in extremity	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	11.9% 5/42 • Number of events 5 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Nervous system disorders Abducens nerve disorder	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Nervous system disorders Cognitive disturbance	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Nervous system disorders Dizziness	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Nervous system disorders Dysgeusia	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Nervous system disorders Extrapyramidal disorder	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Nervous system disorders Facial nerve disorder	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Nervous system disorders Headache	19.6% 9/46 • Number of events 9 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	19.0% 8/42 • Number of events 8 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Nervous system disorders Neuralgia	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Nervous system disorders Peripheral sensory neuropathy	6.5% 3/46 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Nervous system disorders Seizure	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Nervous system disorders Tremor	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Nervous system disorders Trigeminal nerve disorder	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Psychiatric disorders Agitation	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Psychiatric disorders Anxiety	6.5% 3/46 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Psychiatric disorders Confusion	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Psychiatric disorders Depression	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Psychiatric disorders Insomnia	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Psychiatric disorders Psychosis	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Renal and urinary disorders Acute kidney injury	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Renal and urinary disorders Bladder spasm	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Renal and urinary disorders Cystitis noninfective	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Renal and urinary disorders Proteinuria	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Renal and urinary disorders Renal and urinary disorders - Other, specify	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Renal and urinary disorders Urinary frequency	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Renal and urinary disorders Urinary tract obstruction	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Renal and urinary disorders Urinary tract pain	6.5% 3/46 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Respiratory, thoracic and mediastinal disorders Cough	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	9.5% 4/42 • Number of events 4 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	11.9% 5/42 • Number of events 5 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	8.7% 4/46 • Number of events 4 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Skin and subcutaneous tissue disorders Alopecia	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Skin and subcutaneous tissue disorders Body odor	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Skin and subcutaneous tissue disorders Nail loss	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Skin and subcutaneous tissue disorders Pruritus	6.5% 3/46 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	9.5% 4/42 • Number of events 4 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	7.1% 3/42 • Number of events 3 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Skin and subcutaneous tissue disorders Rash acneiform	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Skin and subcutaneous tissue disorders Rash maculo-papular	8.7% 4/46 • Number of events 4 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	28.6% 12/42 • Number of events 12 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	9.5% 4/42 • Number of events 4 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	4.8% 2/42 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Vascular disorders Flushing	0.00% 0/46 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Vascular disorders Hypertension	10.9% 5/46 • Number of events 5 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	23.8% 10/42 • Number of events 10 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Vascular disorders Hypotension	4.3% 2/46 • Number of events 2 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	21.4% 9/42 • Number of events 9 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Vascular disorders Thromboembolic event	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	2.4% 1/42 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
Vascular disorders Vascular disorders - Other, specify	2.2% 1/46 • Number of events 1 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.	0.00% 0/42 For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: resultsreportingcoordinator@childrensoncologygroup.org

Results disclosure agreements

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

Restriction type: OTHER