Trial Outcomes & Findings for Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia (NCT NCT00381680)

NCT ID: NCT00381680

Last Updated: 2024-03-26

Results Overview

Percentage of patients who were event free at 3 years among those on Standard VCR dosing who did not undergo Hematopoietic Stem Cell Transplant (SCT).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 275 participants
• Primary outcome timeframe: 3 years after enrollment
• Results posted on: 2024-03-26

Participant Flow

Participant milestones

Measure	Regimen A: Standard Vincristine Dosing Standard VCR dosing (1.5 mg/m\^2, max 2 mg)	Regimen B: Randomized High Dose Vincristine Regimen Intensive VCR dosing (2 mg/m\^2, max 2.5 mg)
Overall Study STARTED	206	69
Overall Study COMPLETED	81	19
Overall Study NOT COMPLETED	125	50

Reasons for withdrawal

Measure	Regimen A: Standard Vincristine Dosing Standard VCR dosing (1.5 mg/m\^2, max 2 mg)	Regimen B: Randomized High Dose Vincristine Regimen Intensive VCR dosing (2 mg/m\^2, max 2.5 mg)
Overall Study Adverse Event	9	3
Overall Study Death	10	7
Overall Study Lost to Follow-up	3	2
Overall Study Physician Decision	25	6
Overall Study Withdrawal by Subject	3	1
Overall Study Entry onto another COG Trial	1	2
Overall Study Alternative Therapy	11	5
Overall Study Secondary Malignancy	3	0
Overall Study Delay initiation	1	0
Overall Study Stem Cell Transplant	26	10
Overall Study Relapse	18	9
Overall Study Induction Failure	4	1
Overall Study Progression	1	1
Overall Study Other not otherwise specified	7	2
Overall Study Ineligible	3	1

Baseline Characteristics

Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Measure	Regimen A: Standard Vincristine Dosing n=206 Participants Standard VCR dosing (1.5 mg/m\^2, max 2 mg)	Arm B: Randomized High Dose Vincristine Regimen n=69 Participants Intensive VCR dosing (2 mg/m\^2, max 2.5 mg)	Total n=275 Participants Total of all reporting groups
Age, Continuous	17.21 years STANDARD_DEVIATION 5.20 • n=5 Participants	19.62 years STANDARD_DEVIATION 4.84 • n=7 Participants	17.82 years STANDARD_DEVIATION 5.21 • n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants	25 Participants n=7 Participants	121 Participants n=5 Participants
Sex: Female, Male Male	110 Participants n=5 Participants	44 Participants n=7 Participants	154 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	55 Participants n=5 Participants	8 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	145 Participants n=5 Participants	51 Participants n=7 Participants	196 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	3 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) White	157 Participants n=5 Participants	55 Participants n=7 Participants	212 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	28 Participants n=5 Participants	9 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years after enrollment

Population: The analysis is limited to eligible patients on regimen A (Standard VCR dosing) who did not undergo SCT.

Percentage of patients who were event free at 3 years among those on Standard VCR dosing who did not undergo Hematopoietic Stem Cell Transplant (SCT).

Outcome measures

Measure	Regimen A: Standard Vincristine Dosing n=142 Participants Standard VCR dosing (1.5 mg/m\^2, max 2 mg)	Arm B: Randomized High Dose Vincristine Regimen Intensive VCR dosing (2 mg/m\^2, max 2.5 mg)
Event Free Survival. EFS	66.0 percentage of participants EFS at 3 yrs3 Interval 58.0 to 74.0	—

SECONDARY outcome

Timeframe: Up to 107 weeks

Population: The total number of patients for CC or CT genotype is 81 and for high-risk CEP72 genotype is 18. No related by arm data were provided.

Percentage of patients who developed at least 1 episode of grade 2 to 4 neuropathy.

Outcome measures

Measure	Regimen A: Standard Vincristine Dosing n=99 Participants Standard VCR dosing (1.5 mg/m\^2, max 2 mg)	Arm B: Randomized High Dose Vincristine Regimen Intensive VCR dosing (2 mg/m\^2, max 2.5 mg)
Frequency and Severity of Adverse Effects CC or CT genotype	17.3 percentage of participants Interval 10.1 to 27.6	—
Frequency and Severity of Adverse Effects High-risk CEP72 genotype (TT at rs924607)	44.4 percentage of participants Interval 22.4 to 68.7	—

SECONDARY outcome

Timeframe: Up to 36 months

Population: The data were not collected due to the lack of funds.

Percent of unfavorable gene expression profile of early versus late marrow relapse.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: End of Block 1 (35 days) of Induction therapy

Population: This analysis is limited to all eligible patients with isolated BM or combined BM relapse \>= 36 months and had successful MRD determinations at End Block 1.

Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 1

Outcome measures

Measure	Regimen A: Standard Vincristine Dosing n=122 Participants Standard VCR dosing (1.5 mg/m\^2, max 2 mg)	Arm B: Randomized High Dose Vincristine Regimen n=53 Participants Intensive VCR dosing (2 mg/m\^2, max 2.5 mg)
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1	50.8 percentage of participants	41.5 percentage of participants

SECONDARY outcome

Timeframe: End of Block 3 (105 days) of Induction therapy

Population: This analysis is limited to all eligible patients with isolated BM or combined BM relapse \>= 36 months and had successful MRD determinations at End Block 3.

Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 3.

Outcome measures

Measure	Regimen A: Standard Vincristine Dosing n=70 Participants Standard VCR dosing (1.5 mg/m\^2, max 2 mg)	Arm B: Randomized High Dose Vincristine Regimen n=27 Participants Intensive VCR dosing (2 mg/m\^2, max 2.5 mg)
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3	81.4 percentage of participants	88.9 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: The percentage of patients (pts) who were event free at 3 years among those with isolated BM or combined BM relapse \>= 36 months. Pts with MRD \<0.01% at the end of Block 1 (MRD \< 0.01% BL1); MRD \>= 0.01% at the end of Block 1 (MRD\>= 0.01% BL1); MRD \< 0.01% at the end of Block 3 (MRD \< 0.01% BL3);MRD \>=0.01% at the end of Block 3.

Percentage of patients who were event free at 3 years among those with isolated BM or combined BM relapse >= 36 months.

Outcome measures

Measure	Regimen A: Standard Vincristine Dosing n=127 Participants Standard VCR dosing (1.5 mg/m\^2, max 2 mg)	Arm B: Randomized High Dose Vincristine Regimen n=54 Participants Intensive VCR dosing (2 mg/m\^2, max 2.5 mg)
Event Free Survival (EFS) MRD < 0.01% BL1	88.5 percentage of participants Interval 80.4 to 96.6	77.3 percentage of participants Interval 59.8 to 94.8
Event Free Survival (EFS) MRD >= 0.01% BL1	60.0 percentage of participants Interval 47.6 to 72.4	46.2 percentage of participants Interval 27.8 to 64.7
Event Free Survival (EFS) MRD < 0.01% BL3	83.8 percentage of participants Interval 74.0 to 93.5	83.3 percentage of participants Interval 68.4 to 98.2
Event Free Survival (EFS) MRD >= 0.01% BL3	61.5 percentage of participants Interval 35.1 to 88.0	33.3 percentage of participants Interval 0.0 to 86.7

SECONDARY outcome

Timeframe: 3 years

Population: The analysis is limited to eligible patients on Standard VCR dosing who received matched related SCT, excluding patients who had events prior to receiving SCT. And those patients on Regimen A who did not undergo SCT, excluding patients who went off therapy prior to the adjusted starting time.

Adjusted percentage of patients who were event free at 3 years. For patients who received matched donor SCT, EFS was adjusted to start from the actual SCT date. For patients who did not undergo SCT, EFS was adjusted to start from median time to SCT based on patients who received matched related SCT (where patients who had events prior to SCT date were excluded from the calculation of median time to SCT).

Outcome measures

Measure	Regimen A: Standard Vincristine Dosing n=152 Participants Standard VCR dosing (1.5 mg/m\^2, max 2 mg)	Arm B: Randomized High Dose Vincristine Regimen Intensive VCR dosing (2 mg/m\^2, max 2.5 mg)
Adjusted Event Free Survival Did not receive SCT	64.2 adjusted percentage of participants Interval 55.3 to 73.1	—
Adjusted Event Free Survival Received SCT	82.2 adjusted percentage of participants Interval 68.8 to 95.5	—

Adverse Events

Regimen A: Standard Vincristine Dosing

Serious events: 40 serious events

Other events: 189 other events

Deaths: 0 deaths

Arm B: Randomized High Dose Vincristine Regimen

Serious events: 11 serious events

Other events: 66 other events

Deaths: 0 deaths

Serious adverse events

Measure	Regimen A: Standard Vincristine Dosing n=203 participants at risk See detailed description. vincristine sulfate: Given IV prednisone: Given PO doxorubicin hydrochloride: Given IV pegaspargase: Given IM cytarabine: Given IT or IV methotrexate: Given IT or IV dexamethasone: Given PO etoposide: Given IV cyclophosphamide: Given IV leucovorin calcium: Given IV or PO filgrastim: Given IV or SC asparaginase: Given IM mercaptopurine: Given PO	Arm B: Randomized High Dose Vincristine Regimen n=68 participants at risk See detailed description. Closed to accrual as of 09/2010). vincristine sulfate: Given IV prednisone: Given PO doxorubicin hydrochloride: Given IV pegaspargase: Given IM cytarabine: Given IT or IV methotrexate: Given IT or IV dexamethasone: Given PO etoposide: Given IV cyclophosphamide: Given IV leucovorin calcium: Given IV or PO filgrastim: Given IV or SC asparaginase: Given IM mercaptopurine: Given PO
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Blood and lymphatic system disorders Febrile neutropenia	2.0% 4/203 • Number of events 4 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Cardiac disorders Sinus tachycardia	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Cardiac disorders Ventricular arrhythmia	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Abdominal pain	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Anal necrosis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Anal ulcer	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
General disorders Death NOS	7.4% 15/203 • Number of events 15 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
General disorders Edema face	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
General disorders Fever	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
General disorders Multi-organ failure	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Hepatobiliary disorders Hepatic failure	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Appendicitis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Catheter related infection	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Infections and infestations - Other, specify	3.4% 7/203 • Number of events 9 Only eligible patients are included in the toxicity adverse events for both serious and other.	8.8% 6/68 • Number of events 7 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Lung infection	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Meningitis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Mucosal infection	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Sepsis	3.9% 8/203 • Number of events 8 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Upper respiratory infection	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Alanine aminotransferase increased	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Aspartate aminotransferase increased	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Blood bilirubin increased	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Neutrophil count decreased	1.5% 3/203 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Platelet count decreased	1.5% 3/203 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.	2.9% 2/68 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations White blood cell decreased	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Acidosis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Dehydration	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Hypernatremia	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Hyponatremia	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia secondary to oncology chemotherapy	0.99% 2/203 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Intracranial hemorrhage	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	2.9% 2/68 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Myelitis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Seizure	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Stroke	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Vascular disorders Hypotension	2.0% 4/203 • Number of events 4 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Vascular disorders Thromboembolic event	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.

Other adverse events

Measure	Regimen A: Standard Vincristine Dosing n=203 participants at risk See detailed description. vincristine sulfate: Given IV prednisone: Given PO doxorubicin hydrochloride: Given IV pegaspargase: Given IM cytarabine: Given IT or IV methotrexate: Given IT or IV dexamethasone: Given PO etoposide: Given IV cyclophosphamide: Given IV leucovorin calcium: Given IV or PO filgrastim: Given IV or SC asparaginase: Given IM mercaptopurine: Given PO	Arm B: Randomized High Dose Vincristine Regimen n=68 participants at risk See detailed description. Closed to accrual as of 09/2010). vincristine sulfate: Given IV prednisone: Given PO doxorubicin hydrochloride: Given IV pegaspargase: Given IM cytarabine: Given IT or IV methotrexate: Given IT or IV dexamethasone: Given PO etoposide: Given IV cyclophosphamide: Given IV leucovorin calcium: Given IV or PO filgrastim: Given IV or SC asparaginase: Given IM mercaptopurine: Given PO
Gastrointestinal disorders Anal ulcer	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Ascites	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Colitis	4.4% 9/203 • Number of events 10 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Constipation	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Dental caries	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Diarrhea	8.4% 17/203 • Number of events 18 Only eligible patients are included in the toxicity adverse events for both serious and other.	16.2% 11/68 • Number of events 12 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Duodenal hemorrhage	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Duodenal perforation	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Dysphagia	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Enterocolitis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Esophageal pain	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Esophagitis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Fecal incontinence	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Gastric fistula	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Gastritis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Ileus	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Malabsorption	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Mucositis oral	21.2% 43/203 • Number of events 53 Only eligible patients are included in the toxicity adverse events for both serious and other.	25.0% 17/68 • Number of events 27 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Nausea	3.4% 7/203 • Number of events 7 Only eligible patients are included in the toxicity adverse events for both serious and other.	8.8% 6/68 • Number of events 7 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Oral pain	1.5% 3/203 • Number of events 4 Only eligible patients are included in the toxicity adverse events for both serious and other.	8.8% 6/68 • Number of events 9 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Pancreatitis	4.9% 10/203 • Number of events 11 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Rectal mucositis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Rectal pain	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Anal fistula	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Anal mucositis	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Anal pain	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Blood and lymphatic system disorders Anemia	25.1% 51/203 • Number of events 102 Only eligible patients are included in the toxicity adverse events for both serious and other.	32.4% 22/68 • Number of events 40 Only eligible patients are included in the toxicity adverse events for both serious and other.
Blood and lymphatic system disorders Bone marrow hypocellular	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Blood and lymphatic system disorders Febrile neutropenia	62.6% 127/203 • Number of events 250 Only eligible patients are included in the toxicity adverse events for both serious and other.	70.6% 48/68 • Number of events 89 Only eligible patients are included in the toxicity adverse events for both serious and other.
Blood and lymphatic system disorders Hemolysis	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Blood and lymphatic system disorders Leukocytosis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Cardiac disorders Cardiac arrest	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Cardiac disorders Chest pain - cardiac	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Cardiac disorders Heart failure	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Cardiac disorders Left ventricular systolic dysfunction	2.0% 4/203 • Number of events 4 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Cardiac disorders Myocarditis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Cardiac disorders Sinus tachycardia	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Cardiac disorders Wolff-Parkinson-White syndrome	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Ear and labyrinth disorders Ear pain	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Ear and labyrinth disorders Hearing impaired	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Eye disorders Eye pain	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.
Eye disorders Optic nerve disorder	0.49% 1/203 • Number of events 5 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Eye disorders Photophobia	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Eye disorders Retinopathy	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Abdominal distension	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Abdominal pain	6.9% 14/203 • Number of events 16 Only eligible patients are included in the toxicity adverse events for both serious and other.	10.3% 7/68 • Number of events 11 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Rectal ulcer	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Small intestinal mucositis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Stomach pain	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Toothache	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Typhlitis	3.0% 6/203 • Number of events 7 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Gastrointestinal disorders Vomiting	7.4% 15/203 • Number of events 16 Only eligible patients are included in the toxicity adverse events for both serious and other.	8.8% 6/68 • Number of events 6 Only eligible patients are included in the toxicity adverse events for both serious and other.
General disorders Edema limbs	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
General disorders Facial pain	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
General disorders Fatigue	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.
General disorders Fever	15.8% 32/203 • Number of events 37 Only eligible patients are included in the toxicity adverse events for both serious and other.	5.9% 4/68 • Number of events 4 Only eligible patients are included in the toxicity adverse events for both serious and other.
General disorders Flu like symptoms	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
General disorders General disorders and administration site conditions - Other, specify	0.49% 1/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
General disorders Infusion related reaction	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
General disorders Irritability	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
General disorders Localized edema	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
General disorders Non-cardiac chest pain	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
General disorders Pain	4.4% 9/203 • Number of events 9 Only eligible patients are included in the toxicity adverse events for both serious and other.	10.3% 7/68 • Number of events 7 Only eligible patients are included in the toxicity adverse events for both serious and other.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Hepatobiliary disorders Portal hypertension	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Immune system disorders Allergic reaction	2.5% 5/203 • Number of events 5 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Immune system disorders Anaphylaxis	4.9% 10/203 • Number of events 12 Only eligible patients are included in the toxicity adverse events for both serious and other.	10.3% 7/68 • Number of events 8 Only eligible patients are included in the toxicity adverse events for both serious and other.
Immune system disorders Immune system disorders - Other, specify	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Anorectal infection	1.5% 3/203 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Appendicitis	2.5% 5/203 • Number of events 5 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Appendicitis perforated	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Bladder infection	1.5% 3/203 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Bone infection	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Bronchial infection	1.5% 3/203 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Catheter related infection	14.8% 30/203 • Number of events 35 Only eligible patients are included in the toxicity adverse events for both serious and other.	4.4% 3/68 • Number of events 4 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Device related infection	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Enterocolitis infectious	4.4% 9/203 • Number of events 9 Only eligible patients are included in the toxicity adverse events for both serious and other.	7.4% 5/68 • Number of events 7 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Eye infection	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Hepatic infection	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Infections and infestations - Other, specify	49.8% 101/203 • Number of events 207 Only eligible patients are included in the toxicity adverse events for both serious and other.	69.1% 47/68 • Number of events 135 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Joint infection	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Lip infection	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Lung infection	10.8% 22/203 • Number of events 27 Only eligible patients are included in the toxicity adverse events for both serious and other.	10.3% 7/68 • Number of events 8 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Lymph gland infection	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Meningitis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Mucosal infection	2.5% 5/203 • Number of events 5 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Otitis media	2.0% 4/203 • Number of events 5 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Pancreas infection	0.49% 1/203 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Paronychia	1.5% 3/203 • Number of events 4 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Penile infection	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Peripheral nerve infection	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Pleural infection	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Sepsis	12.3% 25/203 • Number of events 32 Only eligible patients are included in the toxicity adverse events for both serious and other.	5.9% 4/68 • Number of events 4 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Sinusitis	2.0% 4/203 • Number of events 5 Only eligible patients are included in the toxicity adverse events for both serious and other.	2.9% 2/68 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Skin infection	7.9% 16/203 • Number of events 16 Only eligible patients are included in the toxicity adverse events for both serious and other.	2.9% 2/68 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Soft tissue infection	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Upper respiratory infection	4.4% 9/203 • Number of events 9 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Urinary tract infection	6.4% 13/203 • Number of events 17 Only eligible patients are included in the toxicity adverse events for both serious and other.	4.4% 3/68 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.
Infections and infestations Wound infection	2.5% 5/203 • Number of events 6 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Injury, poisoning and procedural complications Vascular access complication	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Activated partial thromboplastin time prolonged	2.5% 5/203 • Number of events 5 Only eligible patients are included in the toxicity adverse events for both serious and other.	5.9% 4/68 • Number of events 4 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Alanine aminotransferase increased	38.9% 79/203 • Number of events 153 Only eligible patients are included in the toxicity adverse events for both serious and other.	35.3% 24/68 • Number of events 43 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Alkaline phosphatase increased	1.5% 3/203 • Number of events 5 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Aspartate aminotransferase increased	26.6% 54/203 • Number of events 74 Only eligible patients are included in the toxicity adverse events for both serious and other.	26.5% 18/68 • Number of events 24 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Blood bilirubin increased	7.4% 15/203 • Number of events 18 Only eligible patients are included in the toxicity adverse events for both serious and other.	14.7% 10/68 • Number of events 10 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Cholesterol high	2.0% 4/203 • Number of events 5 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Creatinine increased	2.0% 4/203 • Number of events 4 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Ejection fraction decreased	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Fibrinogen decreased	3.9% 8/203 • Number of events 8 Only eligible patients are included in the toxicity adverse events for both serious and other.	5.9% 4/68 • Number of events 4 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations GGT increased	5.9% 12/203 • Number of events 16 Only eligible patients are included in the toxicity adverse events for both serious and other.	2.9% 2/68 • Number of events 4 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations INR increased	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Investigations - Other, specify	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Lipase increased	8.4% 17/203 • Number of events 19 Only eligible patients are included in the toxicity adverse events for both serious and other.	5.9% 4/68 • Number of events 4 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Lymphocyte count decreased	7.4% 15/203 • Number of events 34 Only eligible patients are included in the toxicity adverse events for both serious and other.	7.4% 5/68 • Number of events 9 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Neutrophil count decreased	62.6% 127/203 • Number of events 421 Only eligible patients are included in the toxicity adverse events for both serious and other.	64.7% 44/68 • Number of events 152 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Platelet count decreased	45.8% 93/203 • Number of events 201 Only eligible patients are included in the toxicity adverse events for both serious and other.	47.1% 32/68 • Number of events 72 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Serum amylase increased	5.4% 11/203 • Number of events 13 Only eligible patients are included in the toxicity adverse events for both serious and other.	4.4% 3/68 • Number of events 4 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Weight gain	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations Weight loss	1.5% 3/203 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Investigations White blood cell decreased	30.0% 61/203 • Number of events 174 Only eligible patients are included in the toxicity adverse events for both serious and other.	36.8% 25/68 • Number of events 70 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Acidosis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	2.9% 2/68 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Alkalosis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Anorexia	9.9% 20/203 • Number of events 23 Only eligible patients are included in the toxicity adverse events for both serious and other.	14.7% 10/68 • Number of events 18 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Dehydration	6.9% 14/203 • Number of events 16 Only eligible patients are included in the toxicity adverse events for both serious and other.	10.3% 7/68 • Number of events 9 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Glucose intolerance	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Hypercalcemia	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Hyperglycemia	12.8% 26/203 • Number of events 35 Only eligible patients are included in the toxicity adverse events for both serious and other.	17.6% 12/68 • Number of events 13 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Hyperkalemia	3.9% 8/203 • Number of events 9 Only eligible patients are included in the toxicity adverse events for both serious and other.	2.9% 2/68 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Hypernatremia	1.5% 3/203 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Hypertriglyceridemia	5.4% 11/203 • Number of events 17 Only eligible patients are included in the toxicity adverse events for both serious and other.	2.9% 2/68 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Hyperuricemia	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	2.9% 2/68 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Hypoalbuminemia	9.4% 19/203 • Number of events 21 Only eligible patients are included in the toxicity adverse events for both serious and other.	10.3% 7/68 • Number of events 9 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Hypocalcemia	9.9% 20/203 • Number of events 23 Only eligible patients are included in the toxicity adverse events for both serious and other.	11.8% 8/68 • Number of events 15 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Hypokalemia	31.0% 63/203 • Number of events 103 Only eligible patients are included in the toxicity adverse events for both serious and other.	29.4% 20/68 • Number of events 35 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Hypomagnesemia	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Hyponatremia	15.3% 31/203 • Number of events 40 Only eligible patients are included in the toxicity adverse events for both serious and other.	17.6% 12/68 • Number of events 15 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Hypophosphatemia	9.9% 20/203 • Number of events 22 Only eligible patients are included in the toxicity adverse events for both serious and other.	5.9% 4/68 • Number of events 4 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Iron overload	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Metabolism and nutrition disorders Tumor lysis syndrome	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Musculoskeletal and connective tissue disorders Avascular necrosis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Musculoskeletal and connective tissue disorders Back pain	3.0% 6/203 • Number of events 6 Only eligible patients are included in the toxicity adverse events for both serious and other.	7.4% 5/68 • Number of events 11 Only eligible patients are included in the toxicity adverse events for both serious and other.
Musculoskeletal and connective tissue disorders Bone pain	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	7.4% 5/68 • Number of events 6 Only eligible patients are included in the toxicity adverse events for both serious and other.
Musculoskeletal and connective tissue disorders Buttock pain	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Musculoskeletal and connective tissue disorders Flank pain	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Musculoskeletal and connective tissue disorders Myalgia	2.0% 4/203 • Number of events 4 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Musculoskeletal and connective tissue disorders Myositis	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Musculoskeletal and connective tissue disorders Pain in extremity	3.4% 7/203 • Number of events 7 Only eligible patients are included in the toxicity adverse events for both serious and other.	10.3% 7/68 • Number of events 11 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Ataxia	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Depressed level of consciousness	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	2.9% 2/68 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Dizziness	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Encephalopathy	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	2.9% 2/68 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Extrapyramidal disorder	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Headache	2.5% 5/203 • Number of events 5 Only eligible patients are included in the toxicity adverse events for both serious and other.	7.4% 5/68 • Number of events 9 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Intracranial hemorrhage	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Leukoencephalopathy	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Neuralgia	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	2.9% 2/68 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Paresthesia	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Peripheral motor neuropathy	4.4% 9/203 • Number of events 11 Only eligible patients are included in the toxicity adverse events for both serious and other.	10.3% 7/68 • Number of events 11 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Peripheral sensory neuropathy	3.4% 7/203 • Number of events 15 Only eligible patients are included in the toxicity adverse events for both serious and other.	14.7% 10/68 • Number of events 19 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Reversible posterior leukoencephalopathy syndrome	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Seizure	1.5% 3/203 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Syncope	3.4% 7/203 • Number of events 7 Only eligible patients are included in the toxicity adverse events for both serious and other.	4.4% 3/68 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Tremor	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Nervous system disorders Trigeminal nerve disorder	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	2.9% 2/68 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.
Psychiatric disorders Agitation	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Psychiatric disorders Anxiety	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	2.9% 2/68 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.
Psychiatric disorders Confusion	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	2.9% 2/68 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.
Psychiatric disorders Depression	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	5.9% 4/68 • Number of events 5 Only eligible patients are included in the toxicity adverse events for both serious and other.
Psychiatric disorders Hallucinations	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Psychiatric disorders Insomnia	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Psychiatric disorders Personality change	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.
Psychiatric disorders Psychosis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Renal and urinary disorders Acute kidney injury	3.0% 6/203 • Number of events 6 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Renal and urinary disorders Renal and urinary disorders - Other, specify	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	2.9% 2/68 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.
Renal and urinary disorders Renal calculi	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Renal and urinary disorders Urinary incontinence	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Renal and urinary disorders Urinary retention	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Aspiration	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Bronchopleural fistula	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Cough	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.5% 3/203 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.	4.4% 3/68 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.4% 7/203 • Number of events 7 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Hypoxia	9.9% 20/203 • Number of events 25 Only eligible patients are included in the toxicity adverse events for both serious and other.	16.2% 11/68 • Number of events 14 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.4% 7/203 • Number of events 7 Only eligible patients are included in the toxicity adverse events for both serious and other.	4.4% 3/68 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.0% 4/203 • Number of events 4 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	2.9% 2/68 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Skin and subcutaneous tissue disorders Pruritus	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.5% 3/203 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	1.5% 3/203 • Number of events 3 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Skin and subcutaneous tissue disorders Skin ulceration	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/203 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Social circumstances Social circumstances - Other, specify	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Surgical and medical procedures Surgical and medical procedures - Other, specify	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Vascular disorders Capillary leak syndrome	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Vascular disorders Hematoma	0.49% 1/203 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.
Vascular disorders Hypertension	2.0% 4/203 • Number of events 5 Only eligible patients are included in the toxicity adverse events for both serious and other.	7.4% 5/68 • Number of events 6 Only eligible patients are included in the toxicity adverse events for both serious and other.
Vascular disorders Hypotension	15.3% 31/203 • Number of events 36 Only eligible patients are included in the toxicity adverse events for both serious and other.	13.2% 9/68 • Number of events 9 Only eligible patients are included in the toxicity adverse events for both serious and other.
Vascular disorders Thromboembolic event	3.9% 8/203 • Number of events 11 Only eligible patients are included in the toxicity adverse events for both serious and other.	1.5% 1/68 • Number of events 1 Only eligible patients are included in the toxicity adverse events for both serious and other.
Vascular disorders Vascular disorders - Other, specify	0.99% 2/203 • Number of events 2 Only eligible patients are included in the toxicity adverse events for both serious and other.	0.00% 0/68 Only eligible patients are included in the toxicity adverse events for both serious and other.

Additional Information

Results Reporting Coordinator

Childrens'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