Trial Outcomes & Findings for Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia (NCT NCT00549848)
NCT ID: NCT00549848
Last Updated: 2022-08-23
Results Overview
The primary objective of this study is to compare the distributions of continuous complete remission of patients randomized on the first day of the continuation phase to receive a higher dose of PEG-asparaginase or to receive the conventional dose (2,500 units/m2). The randomization will occur on the starting day of the continuation phase, at which time all information necessary for performing the randomization should be available. In the rare case that immunophenotype and/or Day-15 MRD is not available, we will make the following assumptions: If immunophenotype is unknown at the time the randomization is to be executed, then it will be assumed B-lineage. If Day-15 MRD is unknown at the time of randomization, then it will be assumed negative (\<0.01%). Past experience indicate that few patients will fall into these unknown categories.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
600 participants
Primary outcome timeframe
3.5 years after the last enrollment up to 12.5 years
Results posted on
2022-08-23
Participant Flow
Between October 29, 2007 and March 26, 2017, 600 patients younger than 19 years of age with newly diagnosed Acute Lymphoblastic Leukemia (ALL) were enrolled.
Two (2) were later found ineligible and excluded. Of the 598 eligible patients, 414 patients were randomized to the two treatment arms, 184 were not randomized for various reasons: * Not Eligible for Randomization (n=41) * Death (n=5) * Transplant (n=13) * Withdrawal of Consent (n=3) * Down's Syndrome (n=12) * Poor Organ Function (n=8) * Parent/Patient Decision (n=70) * Attending Physician Decision (n=4) * Enrollment after Completion of Randomization (n=69)
Participant milestones
| Measure |
PEG 3500 Units/m^2
Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
|
PEG 2500 Units/m^2
Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
|
Not Randomized
Patients who came off study prior to randomization
|
|---|---|---|---|
|
Overall Study
STARTED
|
206
|
208
|
184
|
|
Overall Study
COMPLETED
|
194
|
188
|
133
|
|
Overall Study
NOT COMPLETED
|
12
|
20
|
51
|
Reasons for withdrawal
| Measure |
PEG 3500 Units/m^2
Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
|
PEG 2500 Units/m^2
Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
|
Not Randomized
Patients who came off study prior to randomization
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
4
|
13
|
|
Overall Study
Physician Decision
|
0
|
0
|
4
|
|
Overall Study
Bone Marrow (BM) or Extramedullary Relapse
|
3
|
4
|
4
|
|
Overall Study
Failure to achieve Complete Remission (CR)
|
1
|
0
|
1
|
|
Overall Study
Participant/Family Withdraw
|
2
|
3
|
5
|
|
Overall Study
Second Malignancy
|
1
|
0
|
0
|
|
Overall Study
Transplant
|
3
|
3
|
18
|
|
Overall Study
Unacceptable Toxicity
|
1
|
6
|
6
|
Baseline Characteristics
Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
PEG 3500 Units/m^2
n=206 Participants
Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
|
PEG 2500 Units/m^2
n=208 Participants
Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
|
Not Randomized
n=184 Participants
Patients who came off study prior to randomization
|
Total
n=598 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
7.13 years
STANDARD_DEVIATION 4.78 • n=99 Participants
|
7.04 years
STANDARD_DEVIATION 4.73 • n=107 Participants
|
7.75 years
STANDARD_DEVIATION 5.04 • n=206 Participants
|
7.29 years
STANDARD_DEVIATION 4.85 • n=7 Participants
|
|
Age, Customized
<1 year
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Age, Customized
1-10 years
|
152 Participants
n=99 Participants
|
160 Participants
n=107 Participants
|
131 Participants
n=206 Participants
|
443 Participants
n=7 Participants
|
|
Age, Customized
>10 years
|
49 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
143 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
248 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=99 Participants
|
123 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
350 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Cuban
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Mexican/Chicano
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
NOS Spanish,Hispanic,Latino
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Non Spanish speaking, Non Hispanic
|
182 Participants
n=99 Participants
|
187 Participants
n=107 Participants
|
161 Participants
n=206 Participants
|
530 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Puerto Rican
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
South or Central Amercian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
154 Participants
n=99 Participants
|
167 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
464 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black
|
34 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
88 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
18 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
206 participants
n=99 Participants
|
208 participants
n=107 Participants
|
184 participants
n=206 Participants
|
598 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 3.5 years after the last enrollment up to 12.5 yearsPopulation: Per protocol, the comparison was between the two randomization arms.
The primary objective of this study is to compare the distributions of continuous complete remission of patients randomized on the first day of the continuation phase to receive a higher dose of PEG-asparaginase or to receive the conventional dose (2,500 units/m2). The randomization will occur on the starting day of the continuation phase, at which time all information necessary for performing the randomization should be available. In the rare case that immunophenotype and/or Day-15 MRD is not available, we will make the following assumptions: If immunophenotype is unknown at the time the randomization is to be executed, then it will be assumed B-lineage. If Day-15 MRD is unknown at the time of randomization, then it will be assumed negative (\<0.01%). Past experience indicate that few patients will fall into these unknown categories.
Outcome measures
| Measure |
PEG 3500 Units/m^2
n=206 Participants
Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
|
PEG 2500 Units/m^2
n=208 Participants
Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
|
TOTXVI Not Randomized
Patients who came off study prior to randomization
|
All Eligible Patients in TOTXV
All 498 eligible children with ALL who are treated with risk-directed therapy.
|
|---|---|---|---|---|
|
Percentage of Participants With Continuous Complete Remission of Patients Receiving High-dose and Conventional Dose PEG-asparaginase.
|
91.6 Percentage of participants
Interval 87.7 to 95.5
|
90.7 Percentage of participants
Interval 86.6 to 94.8
|
—
|
—
|
SECONDARY outcome
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 yearsPopulation: Per protocol this objective is to study whether intensifying induction will result in improved outcome compared to TOTXV. All eligible patients entered on TOTXVI will be included in these analyses, as appropriate. Infants will be excluded from the Total XVI for comparisons with TOTXV as only children at least one year of age at diagnosis were treated on Total XV.
To estimate the event-free survival of children with ALL who are treated with risk-directed therapy and to compare the EFS results of TOTXVI with that of TOTXV (NCT00137111). EFS will be measured from the date of complete response to the date of initial failure for patients who fail. Failure includes the traditional endpoints of failure to achieve a complete remission, relapse in any site, secondary malignancy, and death during induction or remission. EFS time will be measured to the date of last contact for patients who are failure free at the time of analysis. The EFS time is defined to be zero (0) for patients who die during induction therapy or fail to achieve a complete remission.
Outcome measures
| Measure |
PEG 3500 Units/m^2
n=201 Participants
Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
|
PEG 2500 Units/m^2
n=205 Participants
Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
|
TOTXVI Not Randomized
n=180 Participants
Patients who came off study prior to randomization
|
All Eligible Patients in TOTXV
n=498 Participants
All 498 eligible children with ALL who are treated with risk-directed therapy.
|
|---|---|---|---|---|
|
Probability of Event-free Survival
|
92.4 Percentage of participants
Interval 88.7 to 96.1
|
91.1 Percentage of participants
Interval 87.0 to 95.2
|
86.3 Percentage of participants
Interval 78.9 to 93.7
|
87.1 Percentage of participants
Interval 84.2 to 90.0
|
SECONDARY outcome
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 yearsPopulation: All eligible patients entered on TOTXVI will be included in these analyses, as appropriate. Infants will be excluded from the Total XVI for comparisons with TOTXV as only children at least one year of age at diagnosis were treated on Total XV.
To estimate the overall survival of children with ALL who are treated with risk-directed therapy and to compare the EFS results of TOTXVI with that of TOTXV.
Outcome measures
| Measure |
PEG 3500 Units/m^2
n=201 Participants
Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
|
PEG 2500 Units/m^2
n=205 Participants
Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
|
TOTXVI Not Randomized
n=180 Participants
Patients who came off study prior to randomization
|
All Eligible Patients in TOTXV
n=498 Participants
All 498 eligible children with ALL who are treated with risk-directed therapy.
|
|---|---|---|---|---|
|
Probability of Overall Survival
|
97.5 Percentage of participants
Interval 95.3 to 99.7
|
95.6 Percentage of participants
Interval 92.7 to 98.5
|
90.8 Percentage of participants
Interval 84.7 to 96.9
|
93.5 Percentage of participants
Interval 91.3 to 95.7
|
SECONDARY outcome
Timeframe: Middle of remission induction, Day 15 in Total XVI and Day 19 in Total XVPopulation: The analysis will compare the proportion of TOTXV patients who had Day-19 MRD≥5% with the proportion of patients on TOTXVI with Day-15 MRD≥5%.
To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD ≥ 5% will result in improved leukemia cytoreduction in this subgroup compared to therapy followed in the TOTXV protocol.
Outcome measures
| Measure |
PEG 3500 Units/m^2
n=203 Participants
Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
|
PEG 2500 Units/m^2
n=206 Participants
Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
|
TOTXVI Not Randomized
n=183 Participants
Patients who came off study prior to randomization
|
All Eligible Patients in TOTXV
n=488 Participants
All 498 eligible children with ALL who are treated with risk-directed therapy.
|
|---|---|---|---|---|
|
Proportion of Participants With Minimal Residual Disease (MRD) on the 15th Day of Remission Induction ≥ 5%
|
22 Participants
|
26 Participants
|
31 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: End of remission induction; day 42 in Total XVI and day 46 in Total XVPopulation: We will compare the proportion of patients with Day-15 MRD≥5% on TOTXVI who are Day-42 MRD positive with the proportion of Day-46 MRD positives in the corresponding subgroup in TOTXV by Fisher's exact test.
To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD ≥ 5% will result in improved leukemia cytoreduction in this subgroup compared to therapy followed in the TOTXV protocol.
Outcome measures
| Measure |
PEG 3500 Units/m^2
n=22 Participants
Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
|
PEG 2500 Units/m^2
n=26 Participants
Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
|
TOTXVI Not Randomized
n=30 Participants
Patients who came off study prior to randomization
|
All Eligible Patients in TOTXV
n=54 Participants
All 498 eligible children with ALL who are treated with risk-directed therapy.
|
|---|---|---|---|---|
|
Proportion of Participants With Minimal Residual Disease (MRD) at End of Remission Induction ≥ 0.01%
|
7 Participants
|
12 Participants
|
20 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 yearsPopulation: Patients with features associated with increased risk for CNS relapse in Total XVI and Total XV.
To assess whether intensification of CNS-directed intrathecal and systemic chemotherapy will improve outcome in patients at high-risk of CNS relapse.
Outcome measures
| Measure |
PEG 3500 Units/m^2
n=121 Participants
Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
|
PEG 2500 Units/m^2
n=125 Participants
Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
|
TOTXVI Not Randomized
n=113 Participants
Patients who came off study prior to randomization
|
All Eligible Patients in TOTXV
n=248 Participants
All 498 eligible children with ALL who are treated with risk-directed therapy.
|
|---|---|---|---|---|
|
Probability of CNS Relapse
|
0.8 Percentage of participants
Interval 0.0 to 2.5
|
1.8 Percentage of participants
Interval 0.0 to 4.3
|
2.7 Percentage of participants
Interval 0.0 to 5.7
|
5.7 Percentage of participants
Interval 2.8 to 8.6
|
Adverse Events
PEG 3500 Units/m^2
Serious events: 0 serious events
Other events: 206 other events
Deaths: 9 deaths
PEG 2500 Units/m^2
Serious events: 0 serious events
Other events: 208 other events
Deaths: 15 deaths
Not Randomized
Serious events: 2 serious events
Other events: 184 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
PEG 3500 Units/m^2
n=206 participants at risk
Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
|
PEG 2500 Units/m^2
n=208 participants at risk
Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
|
Not Randomized
n=184 participants at risk
Patients who came off study prior to randomization
|
|---|---|---|---|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/206 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
0.00%
0/208 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
0.54%
1/184 • Number of events 1 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection, Blood
|
0.00%
0/206 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
0.00%
0/208 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
0.54%
1/184 • Number of events 1 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
Other adverse events
| Measure |
PEG 3500 Units/m^2
n=206 participants at risk
Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
|
PEG 2500 Units/m^2
n=208 participants at risk
Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
|
Not Randomized
n=184 participants at risk
Patients who came off study prior to randomization
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Allergic reaction to Asparaginase
|
13.6%
28/206 • Number of events 36 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
14.4%
30/208 • Number of events 35 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
9.8%
18/184 • Number of events 20 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Vascular disorders
Hypertension
|
24.3%
50/206 • Number of events 58 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
22.6%
47/208 • Number of events 56 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
31.5%
58/184 • Number of events 66 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Vascular disorders
Hypotension
|
7.8%
16/206 • Number of events 17 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
9.1%
19/208 • Number of events 23 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
5.4%
10/184 • Number of events 13 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
75.7%
156/206 • Number of events 395 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
70.7%
147/208 • Number of events 381 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
63.0%
116/184 • Number of events 283 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Metabolism and nutrition disorders
Dehydration
|
9.2%
19/206 • Number of events 22 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
4.8%
10/208 • Number of events 11 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
7.1%
13/184 • Number of events 14 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
17/206 • Number of events 19 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
5.8%
12/208 • Number of events 13 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
6.0%
11/184 • Number of events 12 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic), Oral cavity
|
22.8%
47/206 • Number of events 64 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
30.3%
63/208 • Number of events 78 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
19.6%
36/184 • Number of events 46 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Gastrointestinal disorders
Typhlitis (cecal inflammation)
|
9.2%
19/206 • Number of events 25 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
12.0%
25/208 • Number of events 37 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
10.3%
19/184 • Number of events 21 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
16/206 • Number of events 17 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
7.7%
16/208 • Number of events 18 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
9.2%
17/184 • Number of events 18 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Gastrointestinal disorders
Pancreatitis
|
6.3%
13/206 • Number of events 17 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
9.1%
19/208 • Number of events 24 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
15.2%
28/184 • Number of events 44 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
40.3%
83/206 • Number of events 168 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
29.3%
61/208 • Number of events 103 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
29.9%
55/184 • Number of events 113 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
79.1%
163/206 • Number of events 392 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
76.9%
160/208 • Number of events 404 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
67.4%
124/184 • Number of events 239 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection, Blood
|
18.4%
38/206 • Number of events 49 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
23.1%
48/208 • Number of events 66 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
24.5%
45/184 • Number of events 51 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection, Catheter-related
|
6.8%
14/206 • Number of events 16 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
8.2%
17/208 • Number of events 22 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
4.3%
8/184 • Number of events 8 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection, Lip/perioral
|
4.4%
9/206 • Number of events 13 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
8.2%
17/208 • Number of events 23 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
4.3%
8/184 • Number of events 10 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection, Lung (pneumonia)
|
18.0%
37/206 • Number of events 42 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
22.6%
47/208 • Number of events 63 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
12.0%
22/184 • Number of events 28 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection, Middle ear (otitis media)
|
14.6%
30/206 • Number of events 36 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
18.3%
38/208 • Number of events 48 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
12.0%
22/184 • Number of events 28 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection, Oral cavity-gums (gingivitis)
|
15.5%
32/206 • Number of events 41 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
16.8%
35/208 • Number of events 55 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
14.7%
27/184 • Number of events 36 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection, Rectum
|
3.4%
7/206 • Number of events 7 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
7.2%
15/208 • Number of events 15 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
6.0%
11/184 • Number of events 11 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection, Sinus
|
10.2%
21/206 • Number of events 25 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
11.1%
23/208 • Number of events 25 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
3.3%
6/184 • Number of events 8 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection, Skin (cellulitis)
|
20.4%
42/206 • Number of events 52 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
19.7%
41/208 • Number of events 47 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
21.2%
39/184 • Number of events 49 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection, Upper airway NOS
|
44.7%
92/206 • Number of events 129 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
52.9%
110/208 • Number of events 186 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
46.2%
85/184 • Number of events 143 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection, Urinary tract NOS
|
5.3%
11/206 • Number of events 15 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
6.7%
14/208 • Number of events 22 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
3.8%
7/184 • Number of events 8 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Blood
|
11.2%
23/206 • Number of events 33 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
12.5%
26/208 • Number of events 27 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
10.9%
20/184 • Number of events 25 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related
|
7.8%
16/206 • Number of events 18 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
3.8%
8/208 • Number of events 8 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
4.3%
8/184 • Number of events 8 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Conjunctiva
|
9.7%
20/206 • Number of events 22 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
8.7%
18/208 • Number of events 23 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
8.2%
15/184 • Number of events 16 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, External ear (otitis externa)
|
5.3%
11/206 • Number of events 13 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
6.2%
13/208 • Number of events 15 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
3.8%
7/184 • Number of events 8 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Lip/perioral
|
17.0%
35/206 • Number of events 74 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
13.5%
28/208 • Number of events 56 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
7.6%
14/184 • Number of events 32 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)
|
23.8%
49/206 • Number of events 57 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
22.1%
46/208 • Number of events 50 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
16.3%
30/184 • Number of events 38 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Middle ear (otitis media)
|
40.8%
84/206 • Number of events 197 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
38.5%
80/208 • Number of events 146 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
30.4%
56/184 • Number of events 117 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Oral cavity-gums (gingivitis)
|
24.3%
50/206 • Number of events 82 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
23.1%
48/208 • Number of events 92 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
25.5%
47/184 • Number of events 96 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Sinus
|
32.0%
66/206 • Number of events 136 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
24.5%
51/208 • Number of events 78 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
15.8%
29/184 • Number of events 46 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Skin (cellulitis)
|
44.2%
91/206 • Number of events 167 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
38.5%
80/208 • Number of events 127 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
38.0%
70/184 • Number of events 116 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Ungual (nails)
|
9.2%
19/206 • Number of events 28 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
2.9%
6/208 • Number of events 6 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
4.9%
9/184 • Number of events 12 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS
|
64.6%
133/206 • Number of events 306 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
65.4%
136/208 • Number of events 301 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
57.1%
105/184 • Number of events 262 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS
|
12.1%
25/206 • Number of events 34 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
11.1%
23/208 • Number of events 33 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
8.7%
16/184 • Number of events 32 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Vagina
|
5.3%
11/206 • Number of events 21 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
6.2%
13/208 • Number of events 15 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
4.3%
8/184 • Number of events 15 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
15.5%
32/206 • Number of events 39 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
14.4%
30/208 • Number of events 47 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
15.8%
29/184 • Number of events 41 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
10.7%
22/206 • Number of events 25 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
12.0%
25/208 • Number of events 34 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
11.4%
21/184 • Number of events 23 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
5.3%
11/206 • Number of events 12 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
6.7%
14/208 • Number of events 17 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
10.3%
19/184 • Number of events 24 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
10.7%
22/206 • Number of events 35 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
11.1%
23/208 • Number of events 30 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
13.6%
25/184 • Number of events 38 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
9.2%
19/206 • Number of events 22 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
10.6%
22/208 • Number of events 30 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
7.1%
13/184 • Number of events 13 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
9.2%
19/206 • Number of events 23 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
8.7%
18/208 • Number of events 19 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
9.2%
17/184 • Number of events 18 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Injury, poisoning and procedural complications
Fracture
|
9.2%
19/206 • Number of events 24 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
12.0%
25/208 • Number of events 29 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
11.4%
21/184 • Number of events 23 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis (avascular necrosis)
|
41.3%
85/206 • Number of events 188 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
38.0%
79/208 • Number of events 189 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
31.0%
57/184 • Number of events 152 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Nervous system disorders
Neuropathy: motor
|
25.7%
53/206 • Number of events 53 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
26.0%
54/208 • Number of events 57 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
30.4%
56/184 • Number of events 58 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Nervous system disorders
Seizure
|
6.8%
14/206 • Number of events 14 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
4.3%
9/208 • Number of events 10 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
6.5%
12/184 • Number of events 13 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
17.5%
36/206 • Number of events 45 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
18.3%
38/208 • Number of events 53 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
19.6%
36/184 • Number of events 42 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
5.3%
11/206 • Number of events 12 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
4.8%
10/208 • Number of events 10 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
4.9%
9/184 • Number of events 9 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
12.1%
25/206 • Number of events 25 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
17.3%
36/208 • Number of events 36 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
13.0%
24/184 • Number of events 24 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Injury, poisoning and procedural complications
Thrombosis/embolism (vascular access-related)
|
3.9%
8/206 • Number of events 9 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
5.8%
12/208 • Number of events 12 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
6.5%
12/184 • Number of events 12 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Gastrointestinal disorders
Pain, Abdomen NOS
|
20.9%
43/206 • Number of events 53 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
15.4%
32/208 • Number of events 40 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
12.0%
22/184 • Number of events 28 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Musculoskeletal and connective tissue disorders
Pain, Back
|
10.7%
22/206 • Number of events 26 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
6.7%
14/208 • Number of events 19 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
6.5%
12/184 • Number of events 12 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Musculoskeletal and connective tissue disorders
Pain, Extremity-limb
|
5.3%
11/206 • Number of events 11 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
8.2%
17/208 • Number of events 18 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
2.2%
4/184 • Number of events 4 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
|
Nervous system disorders
Pain, Head/headache
|
10.7%
22/206 • Number of events 27 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
9.6%
20/208 • Number of events 24 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
9.8%
18/184 • Number of events 19 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
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Nervous system disorders
Pain, Neuralgia/peripheral nerve
|
75.2%
155/206 • Number of events 221 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
76.9%
160/208 • Number of events 218 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
|
69.6%
128/184 • Number of events 157 • Through 1 month after therapy completion, approximately 25 months
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place