Trial Outcomes & Findings for Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia (NCT NCT00049517)
NCT ID: NCT00049517
Last Updated: 2023-06-15
Results Overview
Overall survival is defined as the time from randomization in the induction phase to death.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
657 participants
Primary outcome timeframe
Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter.
Results posted on
2023-06-15
Participant Flow
From December 19, 2002 through November 2008, a total of 657 patients were enrolled in the study.
Participant milestones
| Measure |
Standard Daunorubicin Then Autologous HCT
Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts.
The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days.
|
High-dose Daunorubicin Then Autologous HCT
Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts.
The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days.
|
Standard Daunorubicin Then GO/Autologous HCT
Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts.
The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days.
|
High-dose Daunorubicin Then GO/Autologous HCT
Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts.
The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days.
|
Standard Daunorubicin Then Allogeneic HCT or no Consolidation
Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count \> 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available.
|
High-dose Daunorubicin Then Allogeneic HCT or no Consolidation
Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count \> 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available.
|
|---|---|---|---|---|---|---|
|
Induction
STARTED
|
79
|
90
|
63
|
75
|
188
|
162
|
|
Induction
Treated
|
79
|
90
|
63
|
75
|
186
|
160
|
|
Induction
COMPLETED
|
79
|
90
|
63
|
75
|
128
|
108
|
|
Induction
NOT COMPLETED
|
0
|
0
|
0
|
0
|
60
|
54
|
|
Conditioning/Transplant
STARTED
|
79
|
90
|
63
|
75
|
21
|
24
|
|
Conditioning/Transplant
Randomized to Autologous HCT +/- GO
|
59
|
73
|
63
|
75
|
0
|
0
|
|
Conditioning/Transplant
COMPLETED
|
27
|
40
|
25
|
32
|
15
|
18
|
|
Conditioning/Transplant
NOT COMPLETED
|
52
|
50
|
38
|
43
|
6
|
6
|
Reasons for withdrawal
| Measure |
Standard Daunorubicin Then Autologous HCT
Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts.
The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days.
|
High-dose Daunorubicin Then Autologous HCT
Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts.
The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days.
|
Standard Daunorubicin Then GO/Autologous HCT
Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts.
The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days.
|
High-dose Daunorubicin Then GO/Autologous HCT
Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts.
The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days.
|
Standard Daunorubicin Then Allogeneic HCT or no Consolidation
Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count \> 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available.
|
High-dose Daunorubicin Then Allogeneic HCT or no Consolidation
Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count \> 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available.
|
|---|---|---|---|---|---|---|
|
Induction
Disease progression
|
0
|
0
|
0
|
0
|
18
|
11
|
|
Induction
Adverse Event
|
0
|
0
|
0
|
0
|
5
|
7
|
|
Induction
Death
|
0
|
0
|
0
|
0
|
9
|
6
|
|
Induction
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
3
|
|
Induction
Alternative therapy
|
0
|
0
|
0
|
0
|
2
|
2
|
|
Induction
Other complicating disease
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Induction
Reasons not reported
|
0
|
0
|
0
|
0
|
22
|
25
|
|
Conditioning/Transplant
Disease progression
|
14
|
6
|
10
|
6
|
0
|
0
|
|
Conditioning/Transplant
Adverse Event
|
2
|
1
|
4
|
8
|
0
|
0
|
|
Conditioning/Transplant
Death
|
1
|
0
|
0
|
2
|
0
|
0
|
|
Conditioning/Transplant
Withdrawal by Subject
|
4
|
8
|
4
|
7
|
0
|
0
|
|
Conditioning/Transplant
Alternative therapy
|
4
|
4
|
2
|
1
|
1
|
0
|
|
Conditioning/Transplant
Other complicating disease
|
2
|
0
|
0
|
4
|
0
|
1
|
|
Conditioning/Transplant
Reasons not reported
|
25
|
31
|
18
|
15
|
5
|
5
|
Baseline Characteristics
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia
Baseline characteristics by cohort
| Measure |
Standard Daunorubicin (Induction Therapy)
n=330 Participants
Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7.
Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
|
High Dose Daunorubicin (Induction Therapy)
n=327 Participants
Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I.
|
Total
n=657 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
n=5 Participants
|
48 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
322 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
172 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
335 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter.Population: All randomized patients are included in the analysis (intention-to-treat).
Overall survival is defined as the time from randomization in the induction phase to death.
Outcome measures
| Measure |
Standard Daunorubicin
n=330 Participants
Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.
|
High-dose Daunorubicin
n=327 Participants
Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.
|
|---|---|---|
|
Overall Survival (Induction Phase)
|
15.7 months
Interval 12.7 to 19.0
|
23.7 months
Interval 19.0 to 31.7
|
PRIMARY outcome
Timeframe: Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.Population: Only 270 patients who were randomized in the consolidation phase are included in the analysis.
Disease-free survival is defined from the time of the confirmation of a complete remission via biopsy to the relapse of the disease.
Outcome measures
| Measure |
Standard Daunorubicin
n=132 Participants
Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.
|
High-dose Daunorubicin
n=138 Participants
Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.
|
|---|---|---|
|
Disease-free Survival (Consolidation Phase)
|
15.0 Months
Interval 11.4 to 23.9
|
13.6 Months
Interval 10.7 to 18.4
|
SECONDARY outcome
Timeframe: Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.Population: Only 270 patients who were randomized in the consolidation phase are included in the analysis.
Overall survival is defined as the time from randomization in the consolidation phase to death.
Outcome measures
| Measure |
Standard Daunorubicin
n=132 Participants
Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.
|
High-dose Daunorubicin
n=138 Participants
Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.
|
|---|---|---|
|
Overall Survival (Consolidation Phase)
|
35.5 Months
Interval 24.2 to 51.7
|
27.9 Months
Interval 20.3 to 39.5
|
Adverse Events
Standard Daunorubicin (Induction Therapy)
Serious events: 328 serious events
Other events: 319 other events
Deaths: 0 deaths
High Dose Daunorubicin (Induction Therapy)
Serious events: 325 serious events
Other events: 318 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Daunorubicin (Induction Therapy)
n=328 participants at risk
Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Conditioning/Transplant:
Patients receive conditioning comprising busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then undergo autologous peripheral blood stem cell (PBSC) transplantation on day 0. Patients receive sargramostim (GM-CSF) or filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 0 and continuing until blood counts recover.
|
High Dose Daunorubicin (Induction Therapy)
n=325 participants at risk
Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I.
Conditioning/Transplant:
Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 and GM-CSF SC or IV beginning on day 10 and continuing until blood counts recover. Within 2-3 weeks after blood count recovery, patients receive conditioning and undergo autologous PBSC transplantation as in arm I.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bone Marrow Cellularity
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
78.4%
257/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
77.2%
251/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
97.6%
320/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
99.4%
323/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.91%
3/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
1.2%
4/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
97.3%
319/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
93.8%
305/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
97.9%
321/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
98.8%
321/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Transfusion platelets
|
60.7%
199/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
63.4%
206/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Transfusion: PRBCS
|
60.1%
197/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
58.8%
191/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Hematologic-other
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
General disorders
VOD
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.62%
2/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Supraventricular arrhythmias
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
1.8%
6/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Ventricular arrthhmia
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.62%
2/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Arrhythmia-other
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Acute Vascular leak syndrome
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Cardiac ischemia
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Edema
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Hypertension
|
1.5%
5/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.62%
2/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Hypotension
|
2.7%
9/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
3.7%
12/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Thrombosis
|
1.2%
4/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.62%
2/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fatigue
|
5.5%
18/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
5.8%
19/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fever
|
6.7%
22/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
8.9%
29/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Weight gain
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Weight loss
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.92%
3/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
DIC
|
1.5%
5/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.62%
2/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.61%
2/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.62%
2/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.2%
17/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
4.9%
16/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Wound-infectious
|
0.61%
2/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Anorexia
|
7.9%
26/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
9.8%
32/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Colitis
|
1.8%
6/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
2.5%
8/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.61%
2/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.61%
2/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
1.2%
4/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
5.8%
19/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
4.9%
16/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Ear and labyrinth disorders
Stomatitis
|
2.7%
9/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
6.2%
20/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Typhlitis
|
1.8%
6/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
2.8%
9/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
7/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
2.5%
8/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Epistaxis
|
2.4%
8/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
3.1%
10/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Bilirubin Increased
|
4.0%
13/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
4.6%
15/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
1.5%
5/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.92%
3/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
AST increased
|
0.91%
3/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
1.2%
4/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
ALT Increased
|
3.0%
10/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
1.5%
5/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
36.9%
121/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
36.0%
117/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
2.1%
7/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
1.2%
4/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Hypokalemia
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Dyspnea
|
5.5%
18/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
4.0%
13/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Cardiac-Left Ventricular Function
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
1.2%
4/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Cardiac Troponin I
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Injury, poisoning and procedural complications
Operative Injury of Vein/Artery
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Pericardial Effusion/Pericarditis
|
0.61%
2/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Cardiac-other
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.62%
2/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Rigors/chills
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Constitutional symptoms
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
PTT
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Reaction
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Injury, poisoning and procedural complications
Wound - non-infectious
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Skin- Other
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
SIADH
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.92%
3/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Proctitis
|
1.2%
4/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
2.1%
7/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
3.7%
12/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea w/ prior colostomy
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
GI-other
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.92%
3/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Injury, poisoning and procedural complications
Hemorrhage with Grade 3 or 4 Platelets
|
9.1%
30/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
11.1%
36/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Injury, poisoning and procedural complications
Hemorrhage without Grade 3 or 4 Platelets
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
CNS hemorrhage
|
0.61%
2/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Hematemesis
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Renal and urinary disorders
Hematuria
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.62%
2/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.61%
2/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.92%
3/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Injury, poisoning and procedural complications
Hemorrhage Associated with Surgery
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Melena/GI Bleeding
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
1.2%
4/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Petechiae
|
1.5%
5/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.62%
2/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Rectal Bleeding
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Reproductive system and breast disorders
Vaginal Bleeding
|
0.91%
3/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Hemorrhage-Other
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Alkaline phosphatase increased
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
1.8%
6/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection w/ Gr3-4 neutropenia
|
47.0%
154/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
51.7%
168/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Catheter-Related Infection
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
1.2%
4/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection w/ unknown ANC
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection w/o neutropenia
|
3.0%
10/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
4.0%
13/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection- Other
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Acidosis
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.2%
4/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.92%
3/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.4%
11/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
2.8%
9/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.8%
6/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
2.5%
8/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.91%
3/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
1.2%
4/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint, Muscle, Bone-Other
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Confusion
|
0.91%
3/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
1.5%
5/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Depressed Level of consciousness
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.62%
2/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Dizziness/Lightheadedness
|
1.2%
4/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Hallucinations
|
0.61%
2/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Insomnia
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Anxiety/Agitation
|
0.61%
2/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.62%
2/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.62%
2/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-motor
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-sensory
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Seizure
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Speech Impairment
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Syncope
|
1.8%
6/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Ocular-Other
|
0.61%
2/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.2%
4/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.92%
3/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.61%
2/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.92%
3/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
0.61%
2/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.62%
2/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Chest Pain
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Headache
|
1.2%
4/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
1.2%
4/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.92%
3/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.62%
2/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Rectal or Perirectal Pain
|
0.61%
2/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.62%
2/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Pain-other
|
1.5%
5/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
1.2%
4/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
0.91%
3/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.30%
1/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.00%
0/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.5%
18/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
4.0%
13/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.7%
12/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
4.3%
14/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.61%
2/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
1.2%
4/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
2.1%
7/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
3.4%
11/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Creatinine increased
|
0.61%
2/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.31%
1/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Renal and urinary disorders
Renal Failure
|
0.91%
3/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.92%
3/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
0.61%
2/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
0.62%
2/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
Other adverse events
| Measure |
Standard Daunorubicin (Induction Therapy)
n=328 participants at risk
Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Conditioning/Transplant:
Patients receive conditioning comprising busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then undergo autologous peripheral blood stem cell (PBSC) transplantation on day 0. Patients receive sargramostim (GM-CSF) or filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 0 and continuing until blood counts recover.
|
High Dose Daunorubicin (Induction Therapy)
n=325 participants at risk
Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I.
Conditioning/Transplant:
Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 and GM-CSF SC or IV beginning on day 10 and continuing until blood counts recover. Within 2-3 weeks after blood count recovery, patients receive conditioning and undergo autologous PBSC transplantation as in arm I.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
97.3%
319/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
97.8%
318/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
85.7%
281/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
82.2%
267/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
74.1%
243/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
70.8%
230/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
89.9%
295/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
89.8%
292/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Nausea
|
4.9%
16/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
5.5%
18/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fatigue
|
3.4%
11/328 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
5.5%
18/325 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
Additional Information
Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place