Trial Outcomes & Findings for Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (NCT NCT02971397)
NCT ID: NCT02971397
Last Updated: 2026-03-23
Results Overview
Incidence of cardiac toxicity, defined as reduction in LVEF of \>= 10% compared to baseline LVEF and EF =\< 50% on the follow-up scan, assessed using MRI.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Baseline up to 3 months
Results posted on
2026-03-23
Participant Flow
Participant milestones
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Death
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
12
|
Baseline Characteristics
Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
n=40 Participants
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 15.5 • n=10 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 3 monthsPopulation: Patients with both a baseline and a 3 month follow-up MRI
Incidence of cardiac toxicity, defined as reduction in LVEF of \>= 10% compared to baseline LVEF and EF =\< 50% on the follow-up scan, assessed using MRI.
Outcome measures
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
n=21 Participants
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Number of Participants With Cardiac Toxicity, Defined as Reduction in LVEF of >= 10% Compared to Baseline LVEF and EF =< 50% on the Follow-up Scan, Assessed Using MRI
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after last dose of study drugUnexpected toxicities (exclude hematologic and infectious) ≥ grade 3, as measured by CTCAE v 4.0
Outcome measures
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
n=40 Participants
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0
Alkalosis
|
3 events
|
|
Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0
Anxiety
|
2 events
|
|
Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0
Atrial fibrillation
|
3 events
|
|
Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0
Atrial flutter
|
1 events
|
|
Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0
Bone pain
|
2 events
|
|
Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0
Cardiac arrest
|
2 events
|
|
Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0
Encephalopathy
|
2 events
|
|
Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0
Hyperglycemia
|
14 events
|
|
Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0
Hypertension
|
25 events
|
|
Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0
Hypoglycemia
|
2 events
|
|
Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0
Pain
|
2 events
|
|
Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0
Ventricular fibrillation
|
1 events
|
|
Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0
Ventricular tachycardia
|
2 events
|
|
Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0
Blood and lymphatic system disorders - Other: Acute blood loss
|
1 events
|
PRIMARY outcome
Timeframe: 72 hoursWill report these proportions with 95% confidence intervals.
Outcome measures
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
n=40 Participants
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Proportion of Patients Who Complete the Infusion Therapy
|
40 Participants
|
PRIMARY outcome
Timeframe: Approximately 1 year, 5 monthsWill report these proportions with 95% confidence intervals.
Outcome measures
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
n=40 Participants
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Proportion of Patients With Study-related Deviations
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 3 months after last dose of study drugPopulation: Patients with both baseline and 3 month ECHO evaluations
Incidence of cardiac toxicity, defined as reduction in LVEF of \>= 10% compared to baseline LVEF and EF =\< 50% on the follow-up scan, assessed using ECHO.
Outcome measures
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
n=23 Participants
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Incidence of Cardiac Toxicity, Defined as Reduction in LVEF of >= 10% Compared to Baseline LVEF and EF =< 50% on the Follow-up Scan, Assessed Using ECHO
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: The sample size at each time point is restricted from the initial sample size due to loss to follow-up and some invalid/incomplete tests.
Ejection Fraction at baseline, 3 months, and change from baseline to 3 months
Outcome measures
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
n=40 Participants
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
EF, Assessed by MRI and ECHO
3 months ECHO
|
53.6 percentage of ejection fraction
Standard Deviation 8.8
|
|
EF, Assessed by MRI and ECHO
Change from baseline to 3 months ECHO
|
-3.5 percentage of ejection fraction
Standard Deviation 8.6
|
|
EF, Assessed by MRI and ECHO
Baseline MRI
|
59.8 percentage of ejection fraction
Standard Deviation 6.3
|
|
EF, Assessed by MRI and ECHO
3 months MRI
|
56.7 percentage of ejection fraction
Standard Deviation 7.9
|
|
EF, Assessed by MRI and ECHO
Change from baseline to 3 months MRI
|
-4.0 percentage of ejection fraction
Standard Deviation 8.0
|
|
EF, Assessed by MRI and ECHO
Baseline ECHO
|
56.3 percentage of ejection fraction
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline up to 6 months after last dose of study drugPopulation: Patients with baseline and 6 month MRI data
Incidence of cardiac toxicity, defined as reduction in LVEF of \>= 10% compared to baseline LVEF and EF =\< 50% on the follow-up scan, assessed using MRI.
Outcome measures
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
n=9 Participants
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Incidence of Cardiac Toxicity, Defined as Reduction in LVEF of >= 10% Compared to Baseline LVEF and EF =< 50% on the Follow-up Scan, Assessed Using MRI
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 6 months after last dose of study drugPopulation: The sample size at each time point is restricted from the initial sample size due to loss to follow-up and some invalid/incomplete tests.
Left ventricular end diastolic volume assessed by MRI and ECHO at baseline, 3 months, and change from baseline to 3 months.
Outcome measures
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
n=40 Participants
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Change in Left Ventricular End Diastolic Volume, Assessed by MRI and ECHO
Baseline ECHO
|
98.6 ml
Standard Deviation 31.2
|
|
Change in Left Ventricular End Diastolic Volume, Assessed by MRI and ECHO
3 month ECHO
|
99.0 ml
Standard Deviation 35.6
|
|
Change in Left Ventricular End Diastolic Volume, Assessed by MRI and ECHO
Change from baseline to 3 months ECHO
|
-5.2 ml
Standard Deviation 35.3
|
|
Change in Left Ventricular End Diastolic Volume, Assessed by MRI and ECHO
Change from baseline to 3 months MRI
|
2.5 ml
Standard Deviation 28.4
|
|
Change in Left Ventricular End Diastolic Volume, Assessed by MRI and ECHO
Baseline MRI
|
140.4 ml
Standard Deviation 33.2
|
|
Change in Left Ventricular End Diastolic Volume, Assessed by MRI and ECHO
3 months MRI
|
141.3 ml
Standard Deviation 46.5
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: The sample size at each time point is restricted from the initial sample size due to loss to follow-up and some invalid/incomplete tests.
Left ventricular end systolic volume assessed by MRI and ECHO at baseline, 3 months, and change from baseline to 3 months.
Outcome measures
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
n=40 Participants
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Left Ventricular End Systolic Volume, Assessed by MRI and ECHO
Baseline MRI
|
56.9 ml
Standard Deviation 17.7
|
|
Left Ventricular End Systolic Volume, Assessed by MRI and ECHO
3 month MRI
|
60.7 ml
Standard Deviation 22.0
|
|
Left Ventricular End Systolic Volume, Assessed by MRI and ECHO
Change from baseline to 3 months MRI
|
6.0 ml
Standard Deviation 14.1
|
|
Left Ventricular End Systolic Volume, Assessed by MRI and ECHO
Baseline ECHO
|
40.1 ml
Standard Deviation 15.7
|
|
Left Ventricular End Systolic Volume, Assessed by MRI and ECHO
3 months ECHO
|
40.5 ml
Standard Deviation 14.1
|
|
Left Ventricular End Systolic Volume, Assessed by MRI and ECHO
Change from baseline to 3 months ECHO
|
-2.0 ml
Standard Deviation 17.1
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: GLS was not collected in the majority of the patients at both baseline and 3 months due to observed significant variations in image quality and processing, rendering any comparisons to be suboptimal.
Myocardial strain (Global Longitudinal Strain %) assessed by ECHO at baseline, 3 months, and change from baseline to 3 months. GLS was not measured with MRI.
Outcome measures
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
n=13 Participants
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Myocardial Strain, Assessed by MRI and ECHO
Baseline
|
-20.2 percentage of original length
Standard Deviation 2.2
|
|
Myocardial Strain, Assessed by MRI and ECHO
3 months
|
-18.5 percentage of original length
Standard Deviation 2.4
|
|
Myocardial Strain, Assessed by MRI and ECHO
Change: 3 months - baseline
|
1.7 percentage of original length
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: From the date of CR until relapse from CR or death, approximately 1 year, 9 monthsPopulation: Restricted to patients that had CR.
Disease-free survival is calculated for patients who achieve CR and measured from the date of CR until relapse from CR or death. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse.
Outcome measures
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
n=23 Participants
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Disease-free Survival for Those Patients Who Achieve Remission
|
16.5 months
Interval 2.4 to 24.0
|
SECONDARY outcome
Timeframe: Up to 28 daysNumber of patients who had an induction death
Outcome measures
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
n=40 Participants
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Induction Death Rate
|
5 Participants
|
SECONDARY outcome
Timeframe: Approximately 1 year and 9 monthsOverall response rate, defined as CR + CRi. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
Outcome measures
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
n=40 Participants
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Response Rate, Defined as CR + CRi
|
23 Participants
|
Adverse Events
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
Serious events: 40 serious events
Other events: 40 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
n=40 participants at risk
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
17.5%
7/40 • Number of events 8 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other: Acute blood loss
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Cardiac disorders
Cardiac arrest
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Cardiac disorders
Ventricular fibrillation
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Cardiac disorders
Ventricular tachycardia
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Cardiac disorders
Cardiac disorders - Other: Cardiomegaly
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Diarrhea
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
General disorders
General disorders and administration site conditions - Other: Died from disease
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
General disorders
General disorders and administration site conditions - Other: Hypovolemic shock
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Hepatobiliary disorders
Hepatic failure
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Infections and infestations
Lung infection
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Infections and infestations
Sepsis
|
20.0%
8/40 • Number of events 8 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Infections and infestations
Infections and infestations - Other:
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Infections and infestations
Infections and infestations - Other: Influenza A
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Alanine aminotransferase increased
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Aspartate aminotransferase increased
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Blood bilirubin increased
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Lymphocyte count decreased
|
80.0%
32/40 • Number of events 50 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Neutrophil count decreased
|
97.5%
39/40 • Number of events 86 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Platelet count decreased
|
100.0%
40/40 • Number of events 105 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
White blood cell decreased
|
92.5%
37/40 • Number of events 94 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Acidosis
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.0%
2/40 • Number of events 2 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
2/40 • Number of events 2 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Renal and urinary disorders
Chronic kidney disease
|
5.0%
2/40 • Number of events 2 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.0%
4/40 • Number of events 4 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Vascular disorders
Hypotension
|
2.5%
1/40 • Number of events 1 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
Other adverse events
| Measure |
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
n=40 participants at risk
INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Eye disorders
Blurred vision
|
12.5%
5/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Eye disorders
Dry eye
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Eye disorders
Eye pain
|
15.0%
6/40 • Number of events 6 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Ear and labyrinth disorders
Ear pain
|
12.5%
5/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Blood and lymphatic system disorders
Anemia
|
80.0%
32/40 • Number of events 101 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
70.0%
28/40 • Number of events 44 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
52.5%
21/40 • Number of events 30 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other:
|
10.0%
4/40 • Number of events 6 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Cardiac disorders
Atrial fibrillation
|
12.5%
5/40 • Number of events 6 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Cardiac disorders
Chest pain - cardiac
|
15.0%
6/40 • Number of events 6 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Cardiac disorders
Heart failure
|
12.5%
5/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Cardiac disorders
Palpitations
|
12.5%
5/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Cardiac disorders
Pericardial effusion
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Cardiac disorders
Sinus bradycardia
|
15.0%
6/40 • Number of events 6 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Cardiac disorders
Sinus tachycardia
|
52.5%
21/40 • Number of events 30 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Cardiac disorders
Ventricular tachycardia
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Cardiac disorders
Cardiac disorders - Other:
|
25.0%
10/40 • Number of events 14 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Eye disorders
Photophobia
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Eye disorders
Watering eyes
|
7.5%
3/40 • Number of events 4 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Eye disorders
Eye disorders - Other:
|
10.0%
4/40 • Number of events 4 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
8/40 • Number of events 8 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
65.0%
26/40 • Number of events 38 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Ascites
|
10.0%
4/40 • Number of events 4 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Bloating
|
7.5%
3/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Constipation
|
60.0%
24/40 • Number of events 42 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Diarrhea
|
77.5%
31/40 • Number of events 54 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Dry mouth
|
32.5%
13/40 • Number of events 15 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Dysphagia
|
27.5%
11/40 • Number of events 12 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Fecal incontinence
|
12.5%
5/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Flatulence
|
15.0%
6/40 • Number of events 6 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
35.0%
14/40 • Number of events 16 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Hemorrhoids
|
12.5%
5/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Lip pain
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
27.5%
11/40 • Number of events 16 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Nausea
|
77.5%
31/40 • Number of events 65 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
25.0%
10/40 • Number of events 15 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Oral pain
|
47.5%
19/40 • Number of events 37 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
10.0%
4/40 • Number of events 4 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Rectal pain
|
10.0%
4/40 • Number of events 4 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Vomiting
|
65.0%
26/40 • Number of events 36 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other:
|
47.5%
19/40 • Number of events 41 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
General disorders
Chills
|
40.0%
16/40 • Number of events 20 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
General disorders
Edema face
|
17.5%
7/40 • Number of events 7 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
General disorders
Edema limbs
|
70.0%
28/40 • Number of events 51 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
General disorders
Fatigue
|
87.5%
35/40 • Number of events 65 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
General disorders
Fever
|
72.5%
29/40 • Number of events 48 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
General disorders
Injection site reaction
|
17.5%
7/40 • Number of events 8 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
General disorders
Localized edema
|
7.5%
3/40 • Number of events 4 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
General disorders
Malaise
|
22.5%
9/40 • Number of events 10 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
General disorders
Non-cardiac chest pain
|
27.5%
11/40 • Number of events 12 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
General disorders
Pain
|
47.5%
19/40 • Number of events 37 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
General disorders
General disorders and administration site conditions - Other:
|
45.0%
18/40 • Number of events 31 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Infections and infestations
Catheter related infection
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Infections and infestations
Lung infection
|
27.5%
11/40 • Number of events 13 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Infections and infestations
Mucosal infection
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Infections and infestations
Skin infection
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
5/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
4/40 • Number of events 6 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Infections and infestations
Vaginal infection
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Infections and infestations
Infections and infestations - Other:
|
30.0%
12/40 • Number of events 19 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
35.0%
14/40 • Number of events 19 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
5/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other:
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
35.0%
14/40 • Number of events 15 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Alanine aminotransferase increased
|
60.0%
24/40 • Number of events 40 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Alkaline phosphatase increased
|
42.5%
17/40 • Number of events 24 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Aspartate aminotransferase increased
|
65.0%
26/40 • Number of events 41 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Blood bilirubin increased
|
72.5%
29/40 • Number of events 56 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Cardiac troponin I increased
|
25.0%
10/40 • Number of events 10 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Creatinine increased
|
27.5%
11/40 • Number of events 15 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Ejection fraction decreased
|
10.0%
4/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
22.5%
9/40 • Number of events 12 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Lymphocyte count decreased
|
17.5%
7/40 • Number of events 57 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Weight gain
|
47.5%
19/40 • Number of events 30 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
Weight loss
|
55.0%
22/40 • Number of events 33 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Investigations
White blood cell decreased
|
7.5%
3/40 • Number of events 13 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Alkalosis
|
15.0%
6/40 • Number of events 6 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
90.0%
36/40 • Number of events 59 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
15.0%
6/40 • Number of events 8 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
97.5%
39/40 • Number of events 108 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
27.5%
11/40 • Number of events 12 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
32.5%
13/40 • Number of events 13 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
12.5%
5/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
17.5%
7/40 • Number of events 10 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
92.5%
37/40 • Number of events 88 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
80.0%
32/40 • Number of events 45 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
15.0%
6/40 • Number of events 6 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
87.5%
35/40 • Number of events 67 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
90.0%
36/40 • Number of events 76 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
75.0%
30/40 • Number of events 59 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
62.5%
25/40 • Number of events 32 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.5%
7/40 • Number of events 7 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
42.5%
17/40 • Number of events 25 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
22.5%
9/40 • Number of events 14 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
15.0%
6/40 • Number of events 6 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
42.5%
17/40 • Number of events 23 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
10.0%
4/40 • Number of events 4 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.0%
6/40 • Number of events 6 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
8/40 • Number of events 10 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
30.0%
12/40 • Number of events 20 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other:
|
25.0%
10/40 • Number of events 16 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Nervous system disorders
Dizziness
|
35.0%
14/40 • Number of events 20 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Nervous system disorders
Dysgeusia
|
50.0%
20/40 • Number of events 32 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Nervous system disorders
Encephalopathy
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Nervous system disorders
Headache
|
72.5%
29/40 • Number of events 51 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Nervous system disorders
Lethargy
|
22.5%
9/40 • Number of events 9 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
5/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Nervous system disorders
Presyncope
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Nervous system disorders
Somnolence
|
12.5%
5/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Nervous system disorders
Tremor
|
15.0%
6/40 • Number of events 8 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Nervous system disorders
Nervous system disorders - Other:
|
10.0%
4/40 • Number of events 6 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Psychiatric disorders
Agitation
|
10.0%
4/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Psychiatric disorders
Anxiety
|
42.5%
17/40 • Number of events 28 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Psychiatric disorders
Confusion
|
15.0%
6/40 • Number of events 6 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Psychiatric disorders
Delirium
|
10.0%
4/40 • Number of events 4 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Psychiatric disorders
Depression
|
20.0%
8/40 • Number of events 10 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Psychiatric disorders
Hallucinations
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Psychiatric disorders
Insomnia
|
30.0%
12/40 • Number of events 20 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
15.0%
6/40 • Number of events 8 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Renal and urinary disorders
Chronic kidney disease
|
32.5%
13/40 • Number of events 16 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Renal and urinary disorders
Hematuria
|
25.0%
10/40 • Number of events 10 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Renal and urinary disorders
Proteinuria
|
27.5%
11/40 • Number of events 13 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Renal and urinary disorders
Urinary frequency
|
12.5%
5/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
10.0%
4/40 • Number of events 4 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Renal and urinary disorders
Urinary tract pain
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Renal and urinary disorders
Urinary urgency
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other:
|
10.0%
4/40 • Number of events 6 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Reproductive system and breast disorders
Menorrhagia
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
10.0%
4/40 • Number of events 10 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other:
|
12.5%
5/40 • Number of events 7 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
25.0%
10/40 • Number of events 11 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
10.0%
4/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
57.5%
23/40 • Number of events 25 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
70.0%
28/40 • Number of events 38 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
47.5%
19/40 • Number of events 29 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
37.5%
15/40 • Number of events 15 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
30.0%
12/40 • Number of events 17 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
37.5%
15/40 • Number of events 18 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
12.5%
5/40 • Number of events 8 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
22.5%
9/40 • Number of events 12 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
22.5%
9/40 • Number of events 10 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
32.5%
13/40 • Number of events 16 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
25.0%
10/40 • Number of events 10 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other:
|
32.5%
13/40 • Number of events 24 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.0%
6/40 • Number of events 10 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
5/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
37.5%
15/40 • Number of events 29 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
22.5%
9/40 • Number of events 10 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.5%
3/40 • Number of events 3 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
10/40 • Number of events 17 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
4/40 • Number of events 4 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other:
|
65.0%
26/40 • Number of events 55 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Vascular disorders
Hematoma
|
15.0%
6/40 • Number of events 7 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Vascular disorders
Hot flashes
|
10.0%
4/40 • Number of events 8 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Vascular disorders
Hypertension
|
47.5%
19/40 • Number of events 37 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Vascular disorders
Hypotension
|
25.0%
10/40 • Number of events 14 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Vascular disorders
Superficial thrombophlebitis
|
12.5%
5/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
|
Vascular disorders
Thromboembolic event
|
10.0%
4/40 • Number of events 5 • From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
|
Additional Information
Principal Investigator
Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-716-4464
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place