Trial Outcomes & Findings for Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (NCT NCT00671034)
NCT ID: NCT00671034
Last Updated: 2021-04-27
Results Overview
Mean half-life of plasma asparaginase during consolidation and Induction; half-life is defined as the time taken for drug concentration to decrease by half.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
166 participants
Primary outcome timeframe
Post Day 29 of Induction and Post Day 22 of Consolidation
Results posted on
2021-04-27
Participant Flow
Participant milestones
| Measure |
Arm I (Calaspargase Pegol 2100)
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
Arm II (Calaspargase Pegol 2500)
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
Arm III (Pegaspargase 2500)
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
|
|---|---|---|---|
|
Overall Study
STARTED
|
69
|
42
|
55
|
|
Overall Study
COMPLETED
|
30
|
22
|
31
|
|
Overall Study
NOT COMPLETED
|
39
|
20
|
24
|
Reasons for withdrawal
| Measure |
Arm I (Calaspargase Pegol 2100)
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
Arm II (Calaspargase Pegol 2500)
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
Arm III (Pegaspargase 2500)
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
7
|
1
|
|
Overall Study
Death
|
3
|
2
|
1
|
|
Overall Study
Physician Decision
|
12
|
4
|
5
|
|
Overall Study
VHR ALL feature
|
8
|
3
|
5
|
|
Overall Study
Refusal
|
5
|
3
|
5
|
|
Overall Study
includes Alternative therapy, etc.
|
6
|
1
|
7
|
Baseline Characteristics
Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Arm I (Calaspargase Pegol 2100)
n=69 Participants
calaspargase pegol 2100
|
Arm II (Calaspargase Pegol 2500)
n=42 Participants
calaspargase pegol 2500
|
Arm III (Pegaspargase 2500)
n=55 Participants
pegaspargase 2500
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
62 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
11.9 years
STANDARD_DEVIATION 5.58 • n=5 Participants
|
9.9 years
STANDARD_DEVIATION 6.09 • n=7 Participants
|
10.79 years
STANDARD_DEVIATION 5.54 • n=5 Participants
|
11.3 years
STANDARD_DEVIATION 5.72 • n=4 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Post Day 29 of Induction and Post Day 22 of ConsolidationPopulation: Analysis restricted to patients who had PK data collected
Mean half-life of plasma asparaginase during consolidation and Induction; half-life is defined as the time taken for drug concentration to decrease by half.
Outcome measures
| Measure |
Arm III (Pegaspargase 2500)
n=54 Participants
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
|
Arm I (Calaspargase Pegol 2100)
n=69 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
Arm II (Calaspargase Pegol 2500)
n=42 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
|---|---|---|---|
|
Pharmacokinetics (PK) (Half-life of SC-PEG E. Coli L-asparaginase (EZN-2285) Compared to Pegaspargase During Induction and Consolidation Therapy)
Asparaginase half-life during Consolidation
|
117.2 hours
Standard Deviation 49.36
|
415.8 hours
Standard Deviation 148.51
|
355.9 hours
Standard Deviation 133.0
|
|
Pharmacokinetics (PK) (Half-life of SC-PEG E. Coli L-asparaginase (EZN-2285) Compared to Pegaspargase During Induction and Consolidation Therapy)
Asparaginase half-life during Induction
|
126.9 hours
Standard Deviation 50.51
|
305.1 hours
Standard Deviation 98.33
|
321.5 hours
Standard Deviation 118.22
|
SECONDARY outcome
Timeframe: Day 29 of consolidation and inductionPopulation: Patients who had data collected
Plasma Asparaginase Concentration During consolidation and induction.
Outcome measures
| Measure |
Arm III (Pegaspargase 2500)
n=54 Participants
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
|
Arm I (Calaspargase Pegol 2100)
n=69 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
Arm II (Calaspargase Pegol 2500)
n=42 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
|---|---|---|---|
|
Pharmacodynamics (PD)
Plasma Asparaginase Concentration- Consolidation
|
562.1 mIU/mL
Standard Deviation 296.82
|
575.9 mIU/mL
Standard Deviation 233.91
|
617.2 mIU/mL
Standard Deviation 321.41
|
|
Pharmacodynamics (PD)
Plasma Asparaginase Concentration- Induction
|
72.8 mIU/mL
Standard Deviation 47.94
|
271.6 mIU/mL
Standard Deviation 118.17
|
339.6 mIU/mL
Standard Deviation 126.83
|
SECONDARY outcome
Timeframe: End of induction (Day 29)Population: Patients who had data collected.
Percentage of participants with Negative MRD (MRD\<0.01%).
Outcome measures
| Measure |
Arm III (Pegaspargase 2500)
n=47 Participants
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
|
Arm I (Calaspargase Pegol 2100)
n=62 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
Arm II (Calaspargase Pegol 2500)
n=40 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
|---|---|---|---|
|
Percentage of Participants With Minimal Residual Disease (MRD)<0.01% at the End of Induction
|
72.5 Percentage of participants
Interval 58.3 to 84.1
|
65.2 Percentage of participants
Interval 52.4 to 76.5
|
81 Percentage of participants
Interval 65.9 to 91.4
|
SECONDARY outcome
Timeframe: End of induction (Day 29)Population: Patients who had data collected
Complete Remission (CR) rate; where CR is defined as M1 marrow (\< 5% lymphoblasts in the bone marrow)
Outcome measures
| Measure |
Arm III (Pegaspargase 2500)
n=51 Participants
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
|
Arm I (Calaspargase Pegol 2100)
n=66 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
Arm II (Calaspargase Pegol 2500)
n=42 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
|---|---|---|---|
|
Percentage of Participants With Complete Remission at the End of Induction
|
94.1 Percentage of participants
Interval 83.8 to 98.8
|
92.4 Percentage of participants
Interval 83.2 to 97.5
|
97.6 Percentage of participants
Interval 87.4 to 99.9
|
SECONDARY outcome
Timeframe: 5 YearsPercentage of participants who were event free. Event Free Probability defined as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignant neoplasm, remission death) or date of last contact for subjects who are event-free.
Outcome measures
| Measure |
Arm III (Pegaspargase 2500)
n=54 Participants
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
|
Arm I (Calaspargase Pegol 2100)
n=69 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
Arm II (Calaspargase Pegol 2500)
n=42 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
|---|---|---|---|
|
Percentage of Participants With Event-free Survival (EFS)
|
79.34 Percentage of participants
Interval 67.56 to 91.12
|
72.35 Percentage of participants
Interval 60.98 to 83.72
|
80.8 Percentage of participants
Interval 68.3 to 93.3
|
SECONDARY outcome
Timeframe: Days 4, 15, 22 and 29 of InductionPopulation: Patients who had data collected.
The proportion of patients with an asparaginase level of at least 0.1 IU/mL and the proportion with at least 0.4 IU/mL on Days 4, 15, 22 and 29 of Induction compared to Oncaspar
Outcome measures
| Measure |
Arm III (Pegaspargase 2500)
n=54 Participants
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
|
Arm I (Calaspargase Pegol 2100)
n=69 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
Arm II (Calaspargase Pegol 2500)
n=42 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
|---|---|---|---|
|
Asparaginase Level
Level at least 0.1 IU/mL day 4
|
0 percentage of patients
Interval 0.0 to 5.8
|
0 percentage of patients
Interval 0.0 to 8.2
|
0 percentage of patients
Interval 0.0 to 8.8
|
|
Asparaginase Level
Level at least 0.1 IU/mL day 15
|
100 percentage of patients
Interval 98.1 to 100.0
|
98.4 percentage of patients
Interval 91.3 to 100.0
|
100 percentage of patients
Interval 91.2 to 100.0
|
|
Asparaginase Level
Level at least 0.1 IU/mL day 22
|
95.1 percentage of patients
Interval 77.9 to 97.4
|
98.2 percentage of patients
Interval 78.1 to 98.5
|
100 percentage of patients
Interval 91.2 to 100.0
|
|
Asparaginase Level
Level at least 0.1 IU/mL day 29
|
28.6 percentage of patients
Interval 15.3 to 43.7
|
94.9 percentage of patients
Interval 80.1 to 96.4
|
95.0 percentage of patients
Interval 83.1 to 99.4
|
|
Asparaginase Level
Level at least 0.4 IU/mL day 4
|
0 percentage of patients
Interval 0.0 to 5.8
|
0 percentage of patients
Interval 0.0 to 8.2
|
0 percentage of patients
Interval 0.0 to 8.8
|
|
Asparaginase Level
Level at least 0.4 IU/mL day 15
|
93.0 percentage of patients
Interval 80.9 to 98.5
|
75.8 percentage of patients
Interval 63.3 to 85.8
|
95.0 percentage of patients
Interval 83.1 to 99.4
|
|
Asparaginase Level
Level at least 0.4 IU/mL day 22
|
14.6 percentage of patients
Interval 5.3 to 27.9
|
37.5 percentage of patients
Interval 22.3 to 47.0
|
62.5 percentage of patients
Interval 45.8 to 77.3
|
|
Asparaginase Level
Level at least 0.4 IU/mL day 29
|
0 percentage of patients
Interval 0.0 to 8.2
|
13.6 percentage of patients
Interval 5.7 to 23.9
|
27.5 percentage of patients
Interval 14.6 to 43.9
|
SECONDARY outcome
Timeframe: 25 Days Post-dose (Day 29)Population: Patients who had data collected.
The plasma and CSF concentrations of asparagine in ug/ml after administration of EZN-2285 compared to Oncaspar.
Outcome measures
| Measure |
Arm III (Pegaspargase 2500)
n=54 Participants
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
|
Arm I (Calaspargase Pegol 2100)
n=69 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
Arm II (Calaspargase Pegol 2500)
n=42 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
|---|---|---|---|
|
Plasma and CSF Concentrations of Asparagine in ug/ml
CSF asparagine concentration (ug/mL)
|
0.26 ug/mL
Standard Deviation 0.26
|
0.2 ug/mL
Standard Deviation 0.108
|
0.19 ug/mL
Standard Deviation 0.086
|
|
Plasma and CSF Concentrations of Asparagine in ug/ml
Plasma asparagine concentration (ug/mL)
|
0.83 ug/mL
Standard Deviation 2.195
|
0.2 ug/mL
Standard Deviation 0.784
|
0.25 ug/mL
Standard Deviation 1.231
|
SECONDARY outcome
Timeframe: 25 Days Post-dose (Day 29)Population: Patients who had data collected.
Number of Patients with Positive Immunogenicity tests
Outcome measures
| Measure |
Arm III (Pegaspargase 2500)
n=54 Participants
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
|
Arm I (Calaspargase Pegol 2100)
n=69 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
Arm II (Calaspargase Pegol 2500)
n=42 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
|---|---|---|---|
|
Immunogenicity
|
4 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Patients who had data collected. International normalized ratio (INR). Activated partial thromboplastin (APT)
The calculation of AE incidence will be based on the number of patients per AE category. For each patient who has multiple AEs classified to the same category, that patient will be tabulated under the worst toxicity grade for that AE category. The incidence of AEs will be tabulated by treatment arm and by organ class. Special attention will be paid to hypersensitivity, pancreatitis, coagulopathy, infection, neurologic dysfunction and thromboembolic events.
Outcome measures
| Measure |
Arm III (Pegaspargase 2500)
n=43 Participants
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
|
Arm I (Calaspargase Pegol 2100)
n=49 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
Arm II (Calaspargase Pegol 2500)
n=33 Participants
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
|
|---|---|---|---|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Alergic Reaction - Consolidation
|
23.3 Percentage of participants
|
20.4 Percentage of participants
|
27.3 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Alergic Reaction - Delayed Intensification I
|
0.0 Percentage of participants
|
4.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Alergic Reaction - Interim Maintenance I
|
2.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
CNS - Consolidation
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
CNS - Delayed Intensification I
|
2.6 Percentage of participants
|
0.0 Percentage of participants
|
3.8 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
CNS - Interim Maintenance I
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Hyperbilirubinemia - Consolidation
|
30.2 Percentage of participants
|
53.1 Percentage of participants
|
45.5 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Hyperbilirubinemia - Delayed Intensification I
|
10.5 Percentage of participants
|
28.9 Percentage of participants
|
38.5 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Hyperbilirubinemia - Interim Maintenance I
|
33.3 Percentage of participants
|
41.3 Percentage of participants
|
27.6 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Hyperglycemia - Consolidation
|
46.5 Percentage of participants
|
44.9 Percentage of participants
|
42.4 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Hyperglycemia - Delayed Intensification I
|
36.8 Percentage of participants
|
44.4 Percentage of participants
|
61.5 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Hyperglycemia - Interim Maintenance I
|
33.3 Percentage of participants
|
34.8 Percentage of participants
|
44.8 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Hyperlipidemia - Consolidation
|
7.0 Percentage of participants
|
2.0 Percentage of participants
|
3.0 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Hyperlipidemia - Delayed Intensification I
|
0.0 Percentage of participants
|
2.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Hyperlipidemia - Interim Maintenance I
|
2.6 Percentage of participants
|
2.2 Percentage of participants
|
3.4 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
% patients w/INR increase - Consolidation
|
7.0 Percentage of participants
|
6.1 Percentage of participants
|
3.0 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
% pts w/INR increase - Delayed Intensification I
|
0.0 Percentage of participants
|
6.7 Percentage of participants
|
3.8 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
% patients w/INR increase - Interim Maintenance I
|
2.6 Percentage of participants
|
2.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Pancreatitis - Consolidation
|
7.0 Percentage of participants
|
10.2 Percentage of participants
|
6.1 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Pancreatitis -Delayed Intensification I
|
0.0 Percentage of participants
|
2.2 Percentage of participants
|
7.7 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Pancreatitis - Interim Maintenance I
|
2.6 Percentage of participants
|
2.2 Percentage of participants
|
3.4 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
% pts w/prolongation of APT time - Consolidation
|
7.0 Percentage of participants
|
8.2 Percentage of participants
|
9.1 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
% pts w/prolongation APT time -Delayed Intension I
|
18.4 Percentage of participants
|
8.9 Percentage of participants
|
26.9 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
%pts w/prolongation APT time-Interim maintenance I
|
7.7 Percentage of participants
|
6.5 Percentage of participants
|
6.9 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Thrombosis - Consolidation
|
2.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Thrombosis - Delayed Intensification I
|
0.0 Percentage of participants
|
2.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Toxicities During Post Induction Intensification Therapy (All Grades)
Thrombosis - Interim Maintenance I
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 29 of consolidationPopulation: These data will never be collected.
Patients with presence of Antibodies.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Calaspargase Pegol 2100)
Serious events: 54 serious events
Other events: 64 other events
Deaths: 0 deaths
Arm II (Calaspargase Pegol 2500)
Serious events: 34 serious events
Other events: 40 other events
Deaths: 0 deaths
Arm III (Pegaspargase 2500)
Serious events: 32 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Calaspargase Pegol 2100)
n=69 participants at risk
calaspargase pegol 2100
|
Arm II (Calaspargase Pegol 2500)
n=42 participants at risk
calaspargase pegol 2500
|
Arm III (Pegaspargase 2500)
n=54 participants at risk
pegaspargase 2500
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
|
Nervous system disorders
Arachnoiditis
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Nervous system disorders
Ataxia
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Nervous system disorders
Dizziness
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Nervous system disorders
Dysphasia
|
2.9%
2/69 • Number of events 2
|
2.4%
1/42 • Number of events 2
|
0.00%
0/54
|
|
Nervous system disorders
Encephalopathy
|
2.9%
2/69 • Number of events 2
|
7.1%
3/42 • Number of events 3
|
1.9%
1/54 • Number of events 1
|
|
Nervous system disorders
Headache
|
2.9%
2/69 • Number of events 3
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.4%
1/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
|
Nervous system disorders
Leukoencephalopathy
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Nervous system disorders
Seizure
|
2.9%
2/69 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
|
Nervous system disorders
Syncope
|
2.9%
2/69 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
5.6%
3/54 • Number of events 3
|
|
Psychiatric disorders
Agitation
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
|
Psychiatric disorders
Anxiety
|
1.4%
1/69 • Number of events 1
|
4.8%
2/42 • Number of events 2
|
0.00%
0/54
|
|
Psychiatric disorders
Confusion
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Psychiatric disorders
Depression
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
|
Psychiatric disorders
Psychosis
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
3.7%
2/54 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.4%
1/69 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Vascular disorders
Hematoma
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Vascular disorders
Hypertension
|
4.3%
3/69 • Number of events 3
|
0.00%
0/42
|
5.6%
3/54 • Number of events 3
|
|
Vascular disorders
Hypotension
|
10.1%
7/69 • Number of events 7
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
7.2%
5/69 • Number of events 7
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Vascular disorders
Vascular disorders - Other, specify
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
3/69 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.7%
6/69 • Number of events 6
|
7.1%
3/42 • Number of events 3
|
5.6%
3/54 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
3/69 • Number of events 3
|
0.00%
0/42
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
1/69 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/69 • Number of events 1
|
9.5%
4/42 • Number of events 4
|
3.7%
2/54 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemolysis
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Gastrointestinal disorders
Abdominal pain
|
15.9%
11/69 • Number of events 14
|
16.7%
7/42 • Number of events 7
|
7.4%
4/54 • Number of events 4
|
|
Gastrointestinal disorders
Anal pain
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Gastrointestinal disorders
Mucositis oral
|
1.4%
1/69 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
3.7%
2/54 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Gastrointestinal disorders
Oral pain
|
4.3%
3/69 • Number of events 5
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
11.6%
8/69 • Number of events 8
|
14.3%
6/42 • Number of events 6
|
7.4%
4/54 • Number of events 4
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Gastrointestinal disorders
Typhlitis
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/69
|
4.8%
2/42 • Number of events 2
|
3.7%
2/54 • Number of events 2
|
|
General disorders
Death NOS
|
5.8%
4/69 • Number of events 4
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
|
General disorders
Fatigue
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
|
General disorders
Fever
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
General disorders
Irritability
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
General disorders
Pain
|
2.9%
2/69 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
1.9%
1/54 • Number of events 2
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Immune system disorders
Anaphylaxis
|
18.8%
13/69 • Number of events 13
|
26.2%
11/42 • Number of events 11
|
18.5%
10/54 • Number of events 11
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Infections and infestations
Infections and infestations - Other, specify
|
20.3%
14/69 • Number of events 17
|
19.0%
8/42 • Number of events 10
|
7.4%
4/54 • Number of events 6
|
|
Infections and infestations
Infective myositis
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Infections and infestations
Lung infection
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Infections and infestations
Sepsis
|
2.9%
2/69 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.3%
3/69 • Number of events 3
|
7.1%
3/42 • Number of events 3
|
5.6%
3/54 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
5.8%
4/69 • Number of events 4
|
4.8%
2/42 • Number of events 3
|
9.3%
5/54 • Number of events 6
|
|
Investigations
Aspartate aminotransferase increased
|
7.2%
5/69 • Number of events 5
|
4.8%
2/42 • Number of events 2
|
7.4%
4/54 • Number of events 4
|
|
Investigations
Blood bilirubin increased
|
17.4%
12/69 • Number of events 13
|
19.0%
8/42 • Number of events 10
|
18.5%
10/54 • Number of events 12
|
|
Investigations
CPK increased
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Investigations
Cholesterol high
|
2.9%
2/69 • Number of events 4
|
4.8%
2/42 • Number of events 4
|
5.6%
3/54 • Number of events 5
|
|
Investigations
Creatinine increased
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Investigations
Fibrinogen decreased
|
5.8%
4/69 • Number of events 4
|
7.1%
3/42 • Number of events 3
|
5.6%
3/54 • Number of events 3
|
|
Investigations
GGT increased
|
1.4%
1/69 • Number of events 1
|
4.8%
2/42 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
|
Investigations
INR increased
|
1.4%
1/69 • Number of events 1
|
7.1%
3/42 • Number of events 3
|
0.00%
0/54
|
|
Investigations
Investigations - Other, specify
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Investigations
Lipase increased
|
10.1%
7/69 • Number of events 7
|
9.5%
4/42 • Number of events 4
|
7.4%
4/54 • Number of events 4
|
|
Investigations
Lymphocyte count decreased
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Investigations
Neutrophil count decreased
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
3.7%
2/54 • Number of events 2
|
|
Investigations
Platelet count decreased
|
8.7%
6/69 • Number of events 6
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 2
|
|
Investigations
Serum amylase increased
|
11.6%
8/69 • Number of events 8
|
2.4%
1/42 • Number of events 1
|
3.7%
2/54 • Number of events 2
|
|
Investigations
Weight loss
|
4.3%
3/69 • Number of events 3
|
4.8%
2/42 • Number of events 2
|
1.9%
1/54 • Number of events 7
|
|
Investigations
White blood cell decreased
|
1.4%
1/69 • Number of events 1
|
4.8%
2/42 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/69
|
4.8%
2/42 • Number of events 2
|
0.00%
0/54
|
|
Metabolism and nutrition disorders
Anorexia
|
7.2%
5/69 • Number of events 7
|
2.4%
1/42 • Number of events 10
|
1.9%
1/54 • Number of events 7
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
2/69 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
5.6%
3/54 • Number of events 4
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
30.4%
21/69 • Number of events 27
|
33.3%
14/42 • Number of events 16
|
22.2%
12/54 • Number of events 17
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
7.2%
5/69 • Number of events 7
|
9.5%
4/42 • Number of events 7
|
11.1%
6/54 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.2%
5/69 • Number of events 6
|
4.8%
2/42 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.3%
3/69 • Number of events 3
|
0.00%
0/42
|
3.7%
2/54 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.8%
4/69 • Number of events 4
|
0.00%
0/42
|
0.00%
0/54
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.3%
3/69 • Number of events 3
|
0.00%
0/42
|
0.00%
0/54
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
Other adverse events
| Measure |
Arm I (Calaspargase Pegol 2100)
n=69 participants at risk
calaspargase pegol 2100
|
Arm II (Calaspargase Pegol 2500)
n=42 participants at risk
calaspargase pegol 2500
|
Arm III (Pegaspargase 2500)
n=54 participants at risk
pegaspargase 2500
|
|---|---|---|---|
|
Nervous system disorders
Hypoglossal nerve disorder
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
|
Nervous system disorders
Neuralgia
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Nervous system disorders
Seizure
|
1.4%
1/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
|
Nervous system disorders
Syncope
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
|
Nervous system disorders
Tremor
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Nervous system disorders
Vagus nerve disorder
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Nervous system disorders
Vasovagal reaction
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Psychiatric disorders
Agitation
|
1.4%
1/69 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
1.4%
1/69 • Number of events 2
|
0.00%
0/42
|
3.7%
2/54 • Number of events 2
|
|
Psychiatric disorders
Confusion
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Psychiatric disorders
Depression
|
2.9%
2/69 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
0.00%
0/54
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
|
Psychiatric disorders
Personality change
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Psychiatric disorders
Suicidal ideation
|
1.4%
1/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.9%
2/69 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Blood and lymphatic system disorders
Anemia
|
26.1%
18/69 • Number of events 23
|
38.1%
16/42 • Number of events 27
|
42.6%
23/54 • Number of events 33
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
1.4%
1/69 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
53.6%
37/69 • Number of events 88
|
61.9%
26/42 • Number of events 60
|
57.4%
31/54 • Number of events 56
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
1.4%
1/69 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Eye disorders
Eye disorders - Other, specify
|
1.4%
1/69 • Number of events 2
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Eye disorders
Retinal detachment
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
10.1%
7/69 • Number of events 7
|
19.0%
8/42 • Number of events 8
|
11.1%
6/54 • Number of events 9
|
|
Gastrointestinal disorders
Anal pain
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
11.6%
8/69 • Number of events 10
|
9.5%
4/42 • Number of events 6
|
3.7%
2/54 • Number of events 2
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Gastrointestinal disorders
Esophagitis
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Gastrointestinal disorders
Mucositis oral
|
23.2%
16/69 • Number of events 23
|
9.5%
4/42 • Number of events 5
|
13.0%
7/54 • Number of events 9
|
|
Gastrointestinal disorders
Nausea
|
13.0%
9/69 • Number of events 10
|
7.1%
3/42 • Number of events 3
|
3.7%
2/54 • Number of events 3
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
|
Gastrointestinal disorders
Oral pain
|
8.7%
6/69 • Number of events 7
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
1.4%
1/69 • Number of events 1
|
4.8%
2/42 • Number of events 3
|
0.00%
0/54
|
|
Gastrointestinal disorders
Vomiting
|
7.2%
5/69 • Number of events 7
|
4.8%
2/42 • Number of events 3
|
9.3%
5/54 • Number of events 5
|
|
General disorders
Facial pain
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
General disorders
Fatigue
|
4.3%
3/69 • Number of events 4
|
7.1%
3/42 • Number of events 4
|
3.7%
2/54 • Number of events 2
|
|
General disorders
Fever
|
4.3%
3/69 • Number of events 4
|
11.9%
5/42 • Number of events 5
|
5.6%
3/54 • Number of events 3
|
|
General disorders
Irritability
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
General disorders
Multi-organ failure
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
2.9%
2/69 • Number of events 2
|
7.1%
3/42 • Number of events 3
|
3.7%
2/54 • Number of events 2
|
|
General disorders
Pain
|
7.2%
5/69 • Number of events 10
|
2.4%
1/42 • Number of events 1
|
3.7%
2/54 • Number of events 3
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Immune system disorders
Anaphylaxis
|
2.9%
2/69 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
|
Infections and infestations
Anorectal infection
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Infections and infestations
Bladder infection
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Infections and infestations
Enterocolitis infectious
|
7.2%
5/69 • Number of events 6
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 2
|
|
Infections and infestations
Infections and infestations - Other, specify
|
43.5%
30/69 • Number of events 57
|
54.8%
23/42 • Number of events 55
|
33.3%
18/54 • Number of events 39
|
|
Infections and infestations
Infective myositis
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Infections and infestations
Lip infection
|
1.4%
1/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
|
Infections and infestations
Lung infection
|
11.6%
8/69 • Number of events 9
|
7.1%
3/42 • Number of events 3
|
0.00%
0/54
|
|
Infections and infestations
Mucosal infection
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Infections and infestations
Otitis media
|
0.00%
0/69
|
0.00%
0/42
|
3.7%
2/54 • Number of events 2
|
|
Infections and infestations
Pancreas infection
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Infections and infestations
Paronychia
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Infections and infestations
Peripheral nerve infection
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Infections and infestations
Pharyngitis
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
|
Infections and infestations
Scrotal infection
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Infections and infestations
Sepsis
|
4.3%
3/69 • Number of events 3
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
3.7%
2/54 • Number of events 2
|
|
Infections and infestations
Skin infection
|
4.3%
3/69 • Number of events 4
|
4.8%
2/42 • Number of events 2
|
3.7%
2/54 • Number of events 3
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
4.3%
3/69 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
5.8%
4/69 • Number of events 5
|
4.8%
2/42 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
|
Infections and infestations
Wound infection
|
1.4%
1/69 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
36.2%
25/69 • Number of events 71
|
52.4%
22/42 • Number of events 47
|
50.0%
27/54 • Number of events 73
|
|
Investigations
Alkaline phosphatase increased
|
4.3%
3/69 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Investigations
Aspartate aminotransferase increased
|
14.5%
10/69 • Number of events 19
|
26.2%
11/42 • Number of events 15
|
25.9%
14/54 • Number of events 30
|
|
Investigations
Blood bilirubin increased
|
11.6%
8/69 • Number of events 8
|
7.1%
3/42 • Number of events 3
|
5.6%
3/54 • Number of events 3
|
|
Investigations
Cholesterol high
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Investigations
Creatinine increased
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Investigations
GGT increased
|
4.3%
3/69 • Number of events 3
|
7.1%
3/42 • Number of events 7
|
13.0%
7/54 • Number of events 19
|
|
Investigations
Investigations - Other, specify
|
1.4%
1/69 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Investigations
Lipase increased
|
2.9%
2/69 • Number of events 2
|
16.7%
7/42 • Number of events 8
|
9.3%
5/54 • Number of events 5
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/69
|
9.5%
4/42 • Number of events 4
|
0.00%
0/54
|
|
Investigations
Neutrophil count decreased
|
63.8%
44/69 • Number of events 121
|
69.0%
29/42 • Number of events 82
|
66.7%
36/54 • Number of events 92
|
|
Investigations
Platelet count decreased
|
43.5%
30/69 • Number of events 52
|
47.6%
20/42 • Number of events 37
|
40.7%
22/54 • Number of events 33
|
|
Investigations
Serum amylase increased
|
0.00%
0/69
|
4.8%
2/42 • Number of events 2
|
3.7%
2/54 • Number of events 2
|
|
Investigations
Weight gain
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Investigations
Weight loss
|
7.2%
5/69 • Number of events 5
|
9.5%
4/42 • Number of events 5
|
1.9%
1/54 • Number of events 1
|
|
Investigations
White blood cell decreased
|
27.5%
19/69 • Number of events 27
|
38.1%
16/42 • Number of events 34
|
33.3%
18/54 • Number of events 45
|
|
Metabolism and nutrition disorders
Acidosis
|
2.9%
2/69 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
3.7%
2/54 • Number of events 3
|
|
Metabolism and nutrition disorders
Alkalosis
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
15.9%
11/69 • Number of events 13
|
19.0%
8/42 • Number of events 11
|
9.3%
5/54 • Number of events 5
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/69 • Number of events 1
|
11.9%
5/42 • Number of events 5
|
5.6%
3/54 • Number of events 5
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
26.1%
18/69 • Number of events 36
|
26.2%
11/42 • Number of events 12
|
16.7%
9/54 • Number of events 18
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
13.0%
9/69 • Number of events 10
|
4.8%
2/42 • Number of events 3
|
5.6%
3/54 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.9%
2/69 • Number of events 2
|
9.5%
4/42 • Number of events 4
|
3.7%
2/54 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.6%
8/69 • Number of events 11
|
19.0%
8/42 • Number of events 9
|
3.7%
2/54 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
18.8%
13/69 • Number of events 18
|
9.5%
4/42 • Number of events 4
|
20.4%
11/54 • Number of events 15
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/69
|
0.00%
0/42
|
5.6%
3/54 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
36.2%
25/69 • Number of events 40
|
35.7%
15/42 • Number of events 18
|
25.9%
14/54 • Number of events 21
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
3.7%
2/54 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.4%
12/69 • Number of events 12
|
19.0%
8/42 • Number of events 10
|
14.8%
8/54 • Number of events 10
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
13.0%
9/69 • Number of events 10
|
4.8%
2/42 • Number of events 2
|
5.6%
3/54 • Number of events 3
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
3.7%
2/54 • Number of events 7
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
2.9%
2/69 • Number of events 2
|
11.9%
5/42 • Number of events 5
|
1.9%
1/54 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
2/69 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
2.9%
2/69 • Number of events 3
|
4.8%
2/42 • Number of events 2
|
3.7%
2/54 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.2%
5/69 • Number of events 5
|
7.1%
3/42 • Number of events 3
|
7.4%
4/54 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.4%
1/69 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.3%
3/69 • Number of events 3
|
4.8%
2/42 • Number of events 3
|
0.00%
0/54
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/69
|
0.00%
0/42
|
3.7%
2/54 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
3/69 • Number of events 5
|
9.5%
4/42 • Number of events 5
|
5.6%
3/54 • Number of events 3
|
|
Nervous system disorders
Abducens nerve disorder
|
1.4%
1/69 • Number of events 3
|
0.00%
0/42
|
0.00%
0/54
|
|
Nervous system disorders
Ataxia
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Nervous system disorders
Dizziness
|
0.00%
0/69
|
4.8%
2/42 • Number of events 2
|
3.7%
2/54 • Number of events 3
|
|
Nervous system disorders
Dysphasia
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Nervous system disorders
Encephalopathy
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Nervous system disorders
Headache
|
1.4%
1/69 • Number of events 1
|
16.7%
7/42 • Number of events 8
|
13.0%
7/54 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.3%
3/69 • Number of events 5
|
2.4%
1/42 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.6%
8/69 • Number of events 10
|
7.1%
3/42 • Number of events 3
|
9.3%
5/54 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.3%
3/69 • Number of events 3
|
0.00%
0/42
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.7%
6/69 • Number of events 7
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/69 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.4%
1/69 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/69
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/69
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
|
Vascular disorders
Hematoma
|
1.4%
1/69 • Number of events 1
|
0.00%
0/42
|
0.00%
0/54
|
|
Vascular disorders
Hypertension
|
4.3%
3/69 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
|
Vascular disorders
Hypotension
|
5.8%
4/69 • Number of events 4
|
9.5%
4/42 • Number of events 5
|
5.6%
3/54 • Number of events 3
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.9%
2/69 • Number of events 2
|
0.00%
0/42
|
0.00%
0/54
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 626-447-0064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER