Trial Outcomes & Findings for Hypertension Intervention to Reduce Osteonecrosis in Children With Acute Lymphoblastic Leukemia/Lymphoma (NCT NCT04401267)
NCT ID: NCT04401267
Last Updated: 2025-11-03
Results Overview
Involvement of \>=30% of the epiphyseal surface of either the hip or knee by prospective MRI during reinduction II
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
during reinduction II therapy, approximately 9 months into therapy.
Results posted on
2025-11-03
Participant Flow
A total of 51 patients were enrolled into the study from 15OCT2020 to 28DEC2022. Of those, one patient was found to be ineligible to the study. Therefore, only 50 eligible patients will be included in the analyses of the study.
Participant milestones
| Measure |
Intensive Antihypertensive Therapy
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
|
Overall Study
COMPLETED
|
21
|
22
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Intensive Antihypertensive Therapy
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Discontinuation of TOT17 therapy
|
4
|
2
|
|
Overall Study
Found to be Ineligible
|
1
|
0
|
Baseline Characteristics
Hypertension Intervention to Reduce Osteonecrosis in Children With Acute Lymphoblastic Leukemia/Lymphoma
Baseline characteristics by cohort
| Measure |
Intensive Antihypertensive Therapy
n=25 Participants
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Total
n=50 Participants
Total of all reporting groups
|
Conventional (Standard) Antihypertensive Therapy
n=25 Participants
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
|---|---|---|---|
|
Age, Continuous
|
14.01 years
n=15 Participants
|
13.98 years
n=18 Participants
|
13.93 years
n=3 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=15 Participants
|
19 Participants
n=18 Participants
|
9 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=15 Participants
|
31 Participants
n=18 Participants
|
16 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=15 Participants
|
29 Participants
n=18 Participants
|
13 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=15 Participants
|
13 Participants
n=18 Participants
|
7 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=15 Participants
|
5 Participants
n=18 Participants
|
4 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 Participants
n=15 Participants
|
3 Participants
n=18 Participants
|
1 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: during reinduction II therapy, approximately 9 months into therapy.Population: There were 21 of the 25 patients in conventional group, and 23 of the 25 patients in Intensive group reached reinduction II and had the MRI measurement during reinduction II.
Involvement of \>=30% of the epiphyseal surface of either the hip or knee by prospective MRI during reinduction II
Outcome measures
| Measure |
Intensive Antihypertensive Therapy
n=23 Participants
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy
n=21 Participants
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Hip
Conventional (Standard) Antihypertensive Therapy-MRI of Left Hip
|
Intensive Antihypertensive Therapy-MRI-Left Hip
Intensive Antihypertensive Therapy-MRI of Left Hip
|
Conventional (Standard) Antihypertensive Therapy-MRI-Right Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Right Knee
|
Intensive Antihypertensive Therapy-MRI-Right Knee
Intensive Antihypertensive Therapy-MRI of Right Knee
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Left Knee
|
Intensive Antihypertensive Therapy-MRI-Left Knee
Intensive Antihypertensive Therapy-MRI of Left Knee
|
|---|---|---|---|---|---|---|---|---|
|
Extensive Radiographic Osteonecrosis
<30%
|
21 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Extensive Radiographic Osteonecrosis
>=30%
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: any time during leukemia therapy, approximately 2.5 yearsCTCAE grade 2 or high osteonecrosis
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: any time during leukemia therapy, approximately 2.5 yearsCTCAE grade 2 or high osteonecrosis vs. Total 16 matched controls
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: first 9 months of therapyPopulation: Three patients on the Conventional Arm did not have the required measurement. Four patients on the Intensive Arm did not have the required measurement.
Comparison of repeated systolic and diastolic blood pressure measures between randomized treatment arms
Outcome measures
| Measure |
Intensive Antihypertensive Therapy
n=21 Participants
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy
n=22 Participants
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Hip
Conventional (Standard) Antihypertensive Therapy-MRI of Left Hip
|
Intensive Antihypertensive Therapy-MRI-Left Hip
Intensive Antihypertensive Therapy-MRI of Left Hip
|
Conventional (Standard) Antihypertensive Therapy-MRI-Right Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Right Knee
|
Intensive Antihypertensive Therapy-MRI-Right Knee
Intensive Antihypertensive Therapy-MRI of Right Knee
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Left Knee
|
Intensive Antihypertensive Therapy-MRI-Left Knee
Intensive Antihypertensive Therapy-MRI of Left Knee
|
|---|---|---|---|---|---|---|---|---|
|
Blood Pressure Control on Trial
Systolic Blood at Pressure at Month9
|
117.00 mmHg
Interval 91.0 to 139.0
|
114.00 mmHg
Interval 103.0 to 127.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Blood Pressure Control on Trial
Diastolic Blood Pressure at Month9
|
74.00 mmHg
Interval 54.0 to 87.0
|
70.00 mmHg
Interval 60.0 to 82.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeks and 9 months into therapyPopulation: Seven patients on the Conventional Arm and Intensive Arm, Week3, did not have the required measurement. Fourteen patients on the Conventional Arm and Intensive Arm, Month9, did not have the required measurement.
Comparison between randomized treatment arms
Outcome measures
| Measure |
Intensive Antihypertensive Therapy
n=18 Participants
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy
n=18 Participants
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Hip
Conventional (Standard) Antihypertensive Therapy-MRI of Left Hip
|
Intensive Antihypertensive Therapy-MRI-Left Hip
Intensive Antihypertensive Therapy-MRI of Left Hip
|
Conventional (Standard) Antihypertensive Therapy-MRI-Right Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Right Knee
|
Intensive Antihypertensive Therapy-MRI-Right Knee
Intensive Antihypertensive Therapy-MRI of Right Knee
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Left Knee
|
Intensive Antihypertensive Therapy-MRI-Left Knee
Intensive Antihypertensive Therapy-MRI of Left Knee
|
|---|---|---|---|---|---|---|---|---|
|
Biomarkers of Vascular Dysfunction - eNO Synthetase (pg/mL)
Week3
|
267.03 pg/mL
Interval 11.87 to 226392.2
|
187.78 pg/mL
Interval 12.68 to 2030.13
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarkers of Vascular Dysfunction - eNO Synthetase (pg/mL)
Month9
|
266.53 pg/mL
Interval 32.89 to 435387.25
|
193.28 pg/mL
Interval 87.49 to 1096.74
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeks and 9 months into therapyPopulation: Nine patients on the Conventional Arm and 10 on the Intensive Arm, Week3, did not have the required measurement. Four patients on the Conventional Arm and Intensive Arm, Month9, did not have the required measurement.
Comparison between randomized treatment arms
Outcome measures
| Measure |
Intensive Antihypertensive Therapy
n=21 Participants
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy
n=21 Participants
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Hip
Conventional (Standard) Antihypertensive Therapy-MRI of Left Hip
|
Intensive Antihypertensive Therapy-MRI-Left Hip
Intensive Antihypertensive Therapy-MRI of Left Hip
|
Conventional (Standard) Antihypertensive Therapy-MRI-Right Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Right Knee
|
Intensive Antihypertensive Therapy-MRI-Right Knee
Intensive Antihypertensive Therapy-MRI of Right Knee
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Left Knee
|
Intensive Antihypertensive Therapy-MRI-Left Knee
Intensive Antihypertensive Therapy-MRI of Left Knee
|
|---|---|---|---|---|---|---|---|---|
|
Biomarker of Vascular Dysfunction - Von Willebrand Factor (%)
Week3
|
191.00 percentage (%)
Interval 118.0 to 420.0
|
195.00 percentage (%)
Interval 143.0 to 420.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarker of Vascular Dysfunction - Von Willebrand Factor (%)
Month9
|
164.00 percentage (%)
Interval 82.0 to 352.0
|
211.00 percentage (%)
Interval 59.0 to 420.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeks and 9 months into therapyPopulation: One patient on the Conventional Arm and 2 patients on the Intensive Arm, Week3, did not have the required measurement. Five patients on the Conventional Arm and Intensive Arm, Month9, did not have the required measurement.
Comparison between randomized treatment arms
Outcome measures
| Measure |
Intensive Antihypertensive Therapy
n=23 Participants
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy
n=24 Participants
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Hip
Conventional (Standard) Antihypertensive Therapy-MRI of Left Hip
|
Intensive Antihypertensive Therapy-MRI-Left Hip
Intensive Antihypertensive Therapy-MRI of Left Hip
|
Conventional (Standard) Antihypertensive Therapy-MRI-Right Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Right Knee
|
Intensive Antihypertensive Therapy-MRI-Right Knee
Intensive Antihypertensive Therapy-MRI of Right Knee
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Left Knee
|
Intensive Antihypertensive Therapy-MRI-Left Knee
Intensive Antihypertensive Therapy-MRI of Left Knee
|
|---|---|---|---|---|---|---|---|---|
|
Biomarker of Vascular Dysfunction - TNF-alpha (pg/mL)
Week3
|
0.79 pg/mL
Interval 0.36 to 1.86
|
0.87 pg/mL
Interval 0.25 to 1.73
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarker of Vascular Dysfunction - TNF-alpha (pg/mL)
Month9
|
1.44 pg/mL
Interval 0.41 to 26.32
|
1.56 pg/mL
Interval 0.51 to 3.45
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeks and 9 months into therapyPopulation: Nine patients on the Conventional Arm and 8 patients on the Intensive Arm, Week3, did not have the required measurement. Four patients on the Conventional Arm and 5 patients on the Intensive Arm, Month9, did not have the required measurement.
Comparison between randomized treatment arms
Outcome measures
| Measure |
Intensive Antihypertensive Therapy
n=20 Participants
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy
n=21 Participants
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Hip
Conventional (Standard) Antihypertensive Therapy-MRI of Left Hip
|
Intensive Antihypertensive Therapy-MRI-Left Hip
Intensive Antihypertensive Therapy-MRI of Left Hip
|
Conventional (Standard) Antihypertensive Therapy-MRI-Right Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Right Knee
|
Intensive Antihypertensive Therapy-MRI-Right Knee
Intensive Antihypertensive Therapy-MRI of Right Knee
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Left Knee
|
Intensive Antihypertensive Therapy-MRI-Left Knee
Intensive Antihypertensive Therapy-MRI of Left Knee
|
|---|---|---|---|---|---|---|---|---|
|
Biomarker of Vascular Dysfunction - D-dimer (µg/mL)
Week3
|
0.60 µg/mL
Interval 0.27 to 2.77
|
0.85 µg/mL
Interval 0.3 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarker of Vascular Dysfunction - D-dimer (µg/mL)
Month9
|
0.29 µg/mL
Interval 0.27 to 1.1
|
0.44 µg/mL
Interval 0.27 to 4.28
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeks and 9 months into therapyPopulation: Nine patients on the Conventional Arm and the Intensive Arm, Week3, did not have the required measurement. Four patients on the Conventional Arm and 7 patients on the Intensive Arm, Month9, did not have the required measurement.
Comparison between randomized treatment arms
Outcome measures
| Measure |
Intensive Antihypertensive Therapy
n=18 Participants
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy
n=21 Participants
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Hip
Conventional (Standard) Antihypertensive Therapy-MRI of Left Hip
|
Intensive Antihypertensive Therapy-MRI-Left Hip
Intensive Antihypertensive Therapy-MRI of Left Hip
|
Conventional (Standard) Antihypertensive Therapy-MRI-Right Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Right Knee
|
Intensive Antihypertensive Therapy-MRI-Right Knee
Intensive Antihypertensive Therapy-MRI of Right Knee
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Left Knee
|
Intensive Antihypertensive Therapy-MRI-Left Knee
Intensive Antihypertensive Therapy-MRI of Left Knee
|
|---|---|---|---|---|---|---|---|---|
|
Biomarker of Vascular Dysfunction - PAI-1 (AU/mL)
Week3
|
15.80 AU/mL
Interval 3.1 to 71.9
|
17.85 AU/mL
Interval 2.0 to 293.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarker of Vascular Dysfunction - PAI-1 (AU/mL)
Month9
|
41.10 AU/mL
Interval 2.0 to 138.5
|
38.00 AU/mL
Interval 2.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeks and 9 months into therapyPopulation: One patient on the Conventional Arm and 2 patients on the Intensive Arm, Week3, did not have the required measurement. Five patients on the Conventional Arm and the Intensive Arm, Month9, did not have the required measurement.
Comparison between randomized treatment arms
Outcome measures
| Measure |
Intensive Antihypertensive Therapy
n=23 Participants
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy
n=24 Participants
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Hip
Conventional (Standard) Antihypertensive Therapy-MRI of Left Hip
|
Intensive Antihypertensive Therapy-MRI-Left Hip
Intensive Antihypertensive Therapy-MRI of Left Hip
|
Conventional (Standard) Antihypertensive Therapy-MRI-Right Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Right Knee
|
Intensive Antihypertensive Therapy-MRI-Right Knee
Intensive Antihypertensive Therapy-MRI of Right Knee
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Left Knee
|
Intensive Antihypertensive Therapy-MRI-Left Knee
Intensive Antihypertensive Therapy-MRI of Left Knee
|
|---|---|---|---|---|---|---|---|---|
|
Biomarker of Vascular Dysfunction - E-selectin (ng/mL)
Week3
|
23.24 ng/mL
Interval 8.3 to 100.14
|
23.53 ng/mL
Interval 6.36 to 56.64
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarker of Vascular Dysfunction - E-selectin (ng/mL)
Month9
|
53.68 ng/mL
Interval 28.86 to 163.9
|
65.16 ng/mL
Interval 19.37 to 144.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeks and 9 months into therapyPopulation: One patient on the Conventional Arm and 2 patients on the Intensive Arm, Week3, did not have the required measurement. Five patients on the Conventional Arm and the Intensive Arm, Month9, did not have the required measurement.
Comparison between randomized treatment arms
Outcome measures
| Measure |
Intensive Antihypertensive Therapy
n=23 Participants
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy
n=24 Participants
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Hip
Conventional (Standard) Antihypertensive Therapy-MRI of Left Hip
|
Intensive Antihypertensive Therapy-MRI-Left Hip
Intensive Antihypertensive Therapy-MRI of Left Hip
|
Conventional (Standard) Antihypertensive Therapy-MRI-Right Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Right Knee
|
Intensive Antihypertensive Therapy-MRI-Right Knee
Intensive Antihypertensive Therapy-MRI of Right Knee
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Left Knee
|
Intensive Antihypertensive Therapy-MRI-Left Knee
Intensive Antihypertensive Therapy-MRI of Left Knee
|
|---|---|---|---|---|---|---|---|---|
|
Biomarker of Vascular Dysfunction - ICAM-1 (ng/mL)
Week3
|
314.22 ng/mL
Interval 207.09 to 632.73
|
328.79 ng/mL
Interval 166.05 to 515.52
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarker of Vascular Dysfunction - ICAM-1 (ng/mL)
Month9
|
639.25 ng/mL
Interval 244.27 to 1511.56
|
629.13 ng/mL
Interval 344.67 to 1620.85
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeks and 3 months into therapyPopulation: Two patients on the Conventional Arm and Intensive Arm, Week3, did not have the required measurement. Seven patients on the Conventional Arm and 8 patients on the Intensive Arm, Month3, did not have the required measurement.
Comparison between randomized treatment arms
Outcome measures
| Measure |
Intensive Antihypertensive Therapy
n=23 Participants
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy
n=23 Participants
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Hip
Conventional (Standard) Antihypertensive Therapy-MRI of Left Hip
|
Intensive Antihypertensive Therapy-MRI-Left Hip
Intensive Antihypertensive Therapy-MRI of Left Hip
|
Conventional (Standard) Antihypertensive Therapy-MRI-Right Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Right Knee
|
Intensive Antihypertensive Therapy-MRI-Right Knee
Intensive Antihypertensive Therapy-MRI of Right Knee
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Left Knee
|
Intensive Antihypertensive Therapy-MRI-Left Knee
Intensive Antihypertensive Therapy-MRI of Left Knee
|
|---|---|---|---|---|---|---|---|---|
|
Biomarker of Vascular Dysfunction - Arterial Elasticity (ml/mmHg)
Week3
|
10.70 ml/mmHg
Interval 3.0 to 21.0
|
11.60 ml/mmHg
Interval 3.3 to 24.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarker of Vascular Dysfunction - Arterial Elasticity (ml/mmHg)
Month3
|
10.40 ml/mmHg
Interval 3.4 to 25.4
|
12.30 ml/mmHg
Interval 6.8 to 18.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeks and 3 months into therapyPopulation: Two patients on the Conventional Arm and 3 patients on the Intensive Arm, Week3, did not have the required measurement. Eight patients on the Conventional Arm and on the Intensive Arm, Month3, did not have the required measurement.
Comparison between randomized treatment arms
Outcome measures
| Measure |
Intensive Antihypertensive Therapy
n=22 Participants
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy
n=23 Participants
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Hip
Conventional (Standard) Antihypertensive Therapy-MRI of Left Hip
|
Intensive Antihypertensive Therapy-MRI-Left Hip
Intensive Antihypertensive Therapy-MRI of Left Hip
|
Conventional (Standard) Antihypertensive Therapy-MRI-Right Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Right Knee
|
Intensive Antihypertensive Therapy-MRI-Right Knee
Intensive Antihypertensive Therapy-MRI of Right Knee
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Knee
Conventional (Standard) Antihypertensive Therapy-MRI of Left Knee
|
Intensive Antihypertensive Therapy-MRI-Left Knee
Intensive Antihypertensive Therapy-MRI of Left Knee
|
|---|---|---|---|---|---|---|---|---|
|
Biomarker of Vascular Dysfunction - Pulse Wave Velocity (m/Sec)
Week3
|
5.35 m/sec
Interval 3.8 to 8.4
|
5.00 m/sec
Interval 0.5 to 8.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarker of Vascular Dysfunction - Pulse Wave Velocity (m/Sec)
Month3
|
5.30 m/sec
Interval 3.1 to 6.1
|
5.00 m/sec
Interval 3.0 to 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeks and 9 months into therapyPopulation: Four Conventional Arm patients and 2 Intensive Arm patients did not have Week3 right hip (R hip), left hip (L hip), right knee (R knee) and left knee (L knee) MRI. Five Conventional and Intensive Arm patients did not have Month9 R hip MRI. Four Conventional Arm patients and 5 Intensive Arm patients did not have a Month9 L hip and R knee MRI. Three Conventional Arm patients and 5 Intensive Arm patients did not have a Month9 L knee MRI.
Comparison between randomized treatment arms on proportions of MRI identified lesions \>= 30%.
Outcome measures
| Measure |
Intensive Antihypertensive Therapy
n=23 Participants
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy
n=21 Participants
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Hip
n=21 Participants
Conventional (Standard) Antihypertensive Therapy-MRI of Left Hip
|
Intensive Antihypertensive Therapy-MRI-Left Hip
n=23 Participants
Intensive Antihypertensive Therapy-MRI of Left Hip
|
Conventional (Standard) Antihypertensive Therapy-MRI-Right Knee
n=21 Participants
Conventional (Standard) Antihypertensive Therapy-MRI of Right Knee
|
Intensive Antihypertensive Therapy-MRI-Right Knee
n=23 Participants
Intensive Antihypertensive Therapy-MRI of Right Knee
|
Conventional (Standard) Antihypertensive Therapy-MRI-Left Knee
n=22 Participants
Conventional (Standard) Antihypertensive Therapy-MRI of Left Knee
|
Intensive Antihypertensive Therapy-MRI-Left Knee
n=23 Participants
Intensive Antihypertensive Therapy-MRI of Left Knee
|
|---|---|---|---|---|---|---|---|---|
|
Magnetic Resonance Imaging (MRI) of Right and Left Hip and Knee
>=30% at Month9
|
4 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Magnetic Resonance Imaging (MRI) of Right and Left Hip and Knee
>=30% at Week3
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Magnetic Resonance Imaging (MRI) of Right and Left Hip and Knee
<30% at Week3
|
21 Participants
|
20 Participants
|
20 Participants
|
21 Participants
|
20 Participants
|
22 Participants
|
20 Participants
|
22 Participants
|
|
Magnetic Resonance Imaging (MRI) of Right and Left Hip and Knee
<30% at Month9
|
16 Participants
|
17 Participants
|
18 Participants
|
16 Participants
|
18 Participants
|
16 Participants
|
19 Participants
|
16 Participants
|
Adverse Events
Intensive Antihypertensive Therapy
Serious events: 22 serious events
Other events: 24 other events
Deaths: 0 deaths
Conventional (Standard) Antihypertensive Therapy
Serious events: 22 serious events
Other events: 24 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Intensive Antihypertensive Therapy
n=25 participants at risk
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy
n=25 participants at risk
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.0%
4/25 • Number of events 6 • AEs will be collected approximately 9 months, until the end on reinduction.
|
36.0%
9/25 • Number of events 14 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Cardiac disorders
Cardiac disorders - Other
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Gastrointestinal disorders
Colitis
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Gastrointestinal disorders
Pancreatitis
|
16.0%
4/25 • Number of events 4 • AEs will be collected approximately 9 months, until the end on reinduction.
|
16.0%
4/25 • Number of events 4 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
3/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
General disorders
Fever
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
General disorders
Multi-organ failure
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Immune system disorders
Allergic reaction
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Infections and infestations
Catheter related infection
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Infections and infestations
Eye infection
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Investigations
Serum amylase increased
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.0%
3/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
16.0%
4/25 • Number of events 4 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
16.0%
4/25 • Number of events 4 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Nervous system disorders
Headache
|
12.0%
3/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Nervous system disorders
Intracranial hemorrhage
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Nervous system disorders
Seizure
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
12.0%
3/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Nervous system disorders
Syncope
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Psychiatric disorders
Anxiety
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Psychiatric disorders
Mania
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
12.0%
3/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Renal and urinary disorders
Renal calculi
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Vascular disorders
Hypotension
|
12.0%
3/25 • Number of events 4 • AEs will be collected approximately 9 months, until the end on reinduction.
|
16.0%
4/25 • Number of events 4 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Vascular disorders
Thromboembolic event
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Vascular disorders
Visceral arterial ischemia
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Infections and infestations
Infections and infestations - Other
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
12.0%
3/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Infections and infestations
Lung infection
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Infections and infestations
Mucosal infection
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Infections and infestations
Sepsis
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 4 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Infections and infestations
Skin infection
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Infections and infestations
Tooth infection
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Infections and infestations
Upper respiratory infection
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Infections and infestations
Wound infection
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Investigations
Blood antidiuretic hormone abnormal
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Investigations
Lipase increased
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
Other adverse events
| Measure |
Intensive Antihypertensive Therapy
n=25 participants at risk
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
Conventional (Standard) Antihypertensive Therapy
n=25 participants at risk
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
|
|---|---|---|
|
Investigations
Cholesterol high
|
16.0%
4/25 • Number of events 4 • AEs will be collected approximately 9 months, until the end on reinduction.
|
12.0%
3/25 • Number of events 5 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Investigations
Serum amylase increased
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
16.0%
4/25 • Number of events 7 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Vascular disorders
Thromboembolic event
|
16.0%
4/25 • Number of events 6 • AEs will be collected approximately 9 months, until the end on reinduction.
|
12.0%
3/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Investigations
Blood bilirubin increased
|
12.0%
3/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
12.0%
3/25 • Number of events 5 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
12.0%
3/25 • Number of events 4 • AEs will be collected approximately 9 months, until the end on reinduction.
|
12.0%
3/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.0%
2/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 4 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.0%
2/25 • Number of events 4 • AEs will be collected approximately 9 months, until the end on reinduction.
|
12.0%
3/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
16.0%
4/25 • Number of events 6 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.0%
2/25 • Number of events 4 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Infections and infestations
Mucosal infection
|
8.0%
2/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Infections and infestations
Skin infection
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.0%
3/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
2/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Investigations
Lipase increased
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
12.0%
3/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
12.0%
3/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Vascular disorders
Hypotension
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
12.0%
3/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
General disorders
Fever
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Investigations
GGT increased
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 3 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Nervous system disorders
Neuralgia
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
4.0%
1/25 • Number of events 1 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Nervous system disorders
Syncope
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.0%
2/25 • Number of events 2 • AEs will be collected approximately 9 months, until the end on reinduction.
|
0.00%
0/25 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Investigations
Aspartate aminotransferase increased
|
24.0%
6/25 • Number of events 9 • AEs will be collected approximately 9 months, until the end on reinduction.
|
20.0%
5/25 • Number of events 5 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Vascular disorders
Hypertension
|
28.0%
7/25 • Number of events 7 • AEs will be collected approximately 9 months, until the end on reinduction.
|
20.0%
5/25 • Number of events 6 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
5/25 • Number of events 5 • AEs will be collected approximately 9 months, until the end on reinduction.
|
20.0%
5/25 • Number of events 5 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Investigations
Alanine aminotransferase increased
|
52.0%
13/25 • Number of events 33 • AEs will be collected approximately 9 months, until the end on reinduction.
|
52.0%
13/25 • Number of events 27 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
40.0%
10/25 • Number of events 24 • AEs will be collected approximately 9 months, until the end on reinduction.
|
40.0%
10/25 • Number of events 20 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
52.0%
13/25 • Number of events 18 • AEs will be collected approximately 9 months, until the end on reinduction.
|
40.0%
10/25 • Number of events 17 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
24.0%
6/25 • Number of events 13 • AEs will be collected approximately 9 months, until the end on reinduction.
|
32.0%
8/25 • Number of events 12 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Gastrointestinal disorders
Mucositis oral
|
28.0%
7/25 • Number of events 9 • AEs will be collected approximately 9 months, until the end on reinduction.
|
40.0%
10/25 • Number of events 13 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
32.0%
8/25 • Number of events 8 • AEs will be collected approximately 9 months, until the end on reinduction.
|
56.0%
14/25 • Number of events 14 • AEs will be collected approximately 9 months, until the end on reinduction.
|
|
Infections and infestations
Upper respiratory infection
|
28.0%
7/25 • Number of events 7 • AEs will be collected approximately 9 months, until the end on reinduction.
|
28.0%
7/25 • Number of events 8 • AEs will be collected approximately 9 months, until the end on reinduction.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MSA states Site is unable to publish until all completed case report forms have been delivered to Sponsor, (Study Completion). Site shall have the right to publish after publication of a multi-center publication coordinated by the Sponsor or (12) mths. after Study Completion; provided, that prior to any such publication or public release of such data, Site shall furnish Sponsor with a copy of any proposed publication at least (45)days in advance of the proposed publication or presentation date.
- Publication restrictions are in place
Restriction type: OTHER