Trial Outcomes & Findings for Cytarabine and Daunorubicin Hydrochloride or Idarubicin and Cytarabine With or Without Vorinostat in Treating Younger Patients With Previously Untreated Acute Myeloid Leukemia (NCT NCT01802333)
NCT ID: NCT01802333
Last Updated: 2018-12-19
Results Overview
EFS is calculated for all patients from the date of initial registration on study until the first of the following: death from any cause, relapse from remission (CR or CRi) or completion of protocol Induction/Re-Induction therapy without documentation of CR or CRi. 2-year EFS by arm will be estimated using the Kaplan-Meier method. EFS will be compared between Arm I and Arm III and between Arm II and Arm III using Cox proportional hazards regression.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
754 participants
Primary outcome timeframe
EFS assessed for up to 5 years, 2 year EFS reported
Results posted on
2018-12-19
Participant Flow
Participant milestones
| Measure |
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)
INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (High-dose Cytarabine, Idarubicin)
INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)
INDUCTION/RE-INDUCTION: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|---|---|
|
Overall Study
STARTED
|
263
|
267
|
224
|
|
Overall Study
High Risk Patients
|
60
|
61
|
38
|
|
Overall Study
High Risk Patients Achieved CR/CRi
|
38
|
40
|
29
|
|
Overall Study
Known NPM1 Status at Baseline
|
169
|
156
|
142
|
|
Overall Study
Known Cytogenetic Risk at Baseline
|
252
|
250
|
210
|
|
Overall Study
COMPLETED
|
214
|
206
|
161
|
|
Overall Study
NOT COMPLETED
|
49
|
61
|
63
|
Reasons for withdrawal
| Measure |
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)
INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (High-dose Cytarabine, Idarubicin)
INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)
INDUCTION/RE-INDUCTION: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|---|---|
|
Overall Study
Ineligible
|
2
|
6
|
8
|
|
Overall Study
Adverse Event
|
1
|
8
|
8
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
5
|
|
Overall Study
Progression/relapse
|
1
|
3
|
0
|
|
Overall Study
Death
|
7
|
14
|
13
|
|
Overall Study
Other - not protocol specified
|
32
|
22
|
24
|
|
Overall Study
Did not start treatment
|
0
|
2
|
5
|
Baseline Characteristics
Cytarabine and Daunorubicin Hydrochloride or Idarubicin and Cytarabine With or Without Vorinostat in Treating Younger Patients With Previously Untreated Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)
n=261 Participants
INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (High-dose Cytarabine, Idarubicin)
n=261 Participants
INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)
n=216 Participants
INDUCTION/RE-INDUCTIONI: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
Total
n=738 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.3 years
n=5 Participants
|
51.5 years
n=7 Participants
|
48.9 years
n=5 Participants
|
49.8 years
n=4 Participants
|
|
Age, Customized
< 40 years
|
68 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
188 Participants
n=4 Participants
|
|
Age, Customized
>= 40 years
|
193 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
550 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
360 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
378 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
226 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
628 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
218 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
613 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Onset of Leukemia
De novo
|
236 Participants
n=5 Participants
|
236 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
665 Participants
n=4 Participants
|
|
Onset of Leukemia
Tx. related/arose from antecededent hem. disease
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: EFS assessed for up to 5 years, 2 year EFS reportedPopulation: Eligible patients
EFS is calculated for all patients from the date of initial registration on study until the first of the following: death from any cause, relapse from remission (CR or CRi) or completion of protocol Induction/Re-Induction therapy without documentation of CR or CRi. 2-year EFS by arm will be estimated using the Kaplan-Meier method. EFS will be compared between Arm I and Arm III and between Arm II and Arm III using Cox proportional hazards regression.
Outcome measures
| Measure |
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)
n=261 Participants
INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (High-dose Cytarabine, Idarubicin)
n=261 Participants
INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)
n=216 Participants
INDUCTION/RE-INDUCTIONI: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|---|---|
|
Event-free Survival (EFS)
|
0.36 Proportion of participants
Interval 0.3 to 0.42
|
0.41 Proportion of participants
Interval 0.35 to 0.46
|
0.37 Proportion of participants
Interval 0.3 to 0.43
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible patients with high-risk AML who achieved CR or CRi, regardless of treatment arm.
The goal of the transplant objective is to determine whether it is possible to conduct allogeneic HCT on 60% or more of adults with high-risk AML in first complete remission (alternative). If 40% or fewer of high-risk patients in CR can be transplanted, the proposed transplant support system will not be considered feasible. A one-sided binomial test compared to the null transplant rate will be conducted.
Outcome measures
| Measure |
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)
n=107 Participants
INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (High-dose Cytarabine, Idarubicin)
INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)
INDUCTION/RE-INDUCTIONI: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|---|---|
|
Rate of Allogeneic HCT
|
65 percentage of patients
Interval 56.0 to 74.0
|
—
|
—
|
SECONDARY outcome
Timeframe: DFS assessed for up to 5 years, 2 year DFS reportedPopulation: Eligible, high risk patients, regardless of treatment arm.
DFS is calculated for patients who have achieved a CR or CRi (complete response with incomplete blood count recovery). DFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse. 2-year DFS for high risk patients will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)
n=159 Participants
INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (High-dose Cytarabine, Idarubicin)
INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)
INDUCTION/RE-INDUCTIONI: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|---|---|
|
Disease-free Survival (DFS) Among High Risk Patients
|
0.30 Proportion of participants
Interval 0.21 to 0.39
|
—
|
—
|
SECONDARY outcome
Timeframe: EFS assessed for up to 5 years, 2 year EFS reportedPopulation: Eligible patients
EFS is calculated for all patients from the date of initial registration on study until the first of the following: death from any cause, relapse from remission (CR or CRi) or completion of protocol Induction/Re-Induction therapy without documentation of CR or CRi. A two-sided test of the hazard ratio (HR) of 7:3: IA (versus the null hypothesis of HR =1) will be done using a proportional hazards regression model with the stratification factors included as covariates. 2-year EFS by arm will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)
n=261 Participants
INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (High-dose Cytarabine, Idarubicin)
n=261 Participants
INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)
INDUCTION/RE-INDUCTIONI: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|---|---|
|
EFS of Arm I Compared to Arm II
|
0.36 Proportion of participants
Interval 0.3 to 0.42
|
0.41 Proportion of participants
Interval 0.35 to 0.46
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible patients who started treatment
Number of patients with Grade 3-5 adverse events that were possibly, probably or definitely related to study drug are reported by given type of adverse event.
Outcome measures
| Measure |
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)
n=261 Participants
INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (High-dose Cytarabine, Idarubicin)
n=259 Participants
INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)
n=211 Participants
INDUCTION/RE-INDUCTIONI: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|---|---|
|
Frequency and Severity of Toxicities
Anal pain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Anal ulcer
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Atelectasis
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Atrial fibrillation
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Atrial flutter
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Atrioventricular block complete
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Duodenal hemorrhage
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Dyspepsia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Eye infection
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Fatigue
|
14 Participants
|
18 Participants
|
13 Participants
|
|
Frequency and Severity of Toxicities
Hematoma
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Hematuria
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Hepatic failure
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Hepatic infection
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Hepatobiliary disorders - Other, specify
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Hyperglycemia
|
5 Participants
|
12 Participants
|
16 Participants
|
|
Frequency and Severity of Toxicities
Hyperhidrosis
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Hyperkalemia
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Hypermagnesemia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Hypernatremia
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Hypertension
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Frequency and Severity of Toxicities
Hyperuricemia
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Hypoalbuminemia
|
5 Participants
|
8 Participants
|
8 Participants
|
|
Frequency and Severity of Toxicities
Hypocalcemia
|
8 Participants
|
17 Participants
|
25 Participants
|
|
Frequency and Severity of Toxicities
Hypoglycemia
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Hypokalemia
|
18 Participants
|
20 Participants
|
24 Participants
|
|
Frequency and Severity of Toxicities
Hyponatremia
|
20 Participants
|
20 Participants
|
9 Participants
|
|
Frequency and Severity of Toxicities
Hypophosphatemia
|
21 Participants
|
31 Participants
|
31 Participants
|
|
Frequency and Severity of Toxicities
Hypoxia
|
2 Participants
|
4 Participants
|
9 Participants
|
|
Frequency and Severity of Toxicities
Ileus
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Infections and infestations - Other, specify
|
18 Participants
|
21 Participants
|
14 Participants
|
|
Frequency and Severity of Toxicities
Infective myositis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Injury, poison and procedural complications-Other
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Intracranial hemorrhage
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Investigations - Other, specify
|
1 Participants
|
6 Participants
|
3 Participants
|
|
Frequency and Severity of Toxicities
Irregular menstruation
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Jejunal obstruction
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Kidney infection
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Laryngeal edema
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Left ventricular systolic dysfunction
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Leukocytosis
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Lipase increased
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Lower gastrointestinal hemorrhage
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Frequency and Severity of Toxicities
Lung infection
|
21 Participants
|
22 Participants
|
14 Participants
|
|
Frequency and Severity of Toxicities
Lymphocyte count decreased
|
89 Participants
|
107 Participants
|
77 Participants
|
|
Frequency and Severity of Toxicities
Menorrhagia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Mucosal infection
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Mucositis oral
|
19 Participants
|
18 Participants
|
11 Participants
|
|
Frequency and Severity of Toxicities
Multi-organ failure
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Frequency and Severity of Toxicities
Musculoskeletal and connective tiss disorder-Other
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Myalgia
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Nausea
|
7 Participants
|
15 Participants
|
5 Participants
|
|
Frequency and Severity of Toxicities
Neck edema
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Nervous system disorders - Other, specify
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Neutrophil count decreased
|
141 Participants
|
128 Participants
|
104 Participants
|
|
Frequency and Severity of Toxicities
Non-cardiac chest pain
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Pain
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Pain in extremity
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Palmar-plantar erythrodysesthesia syndrome
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Papulopustular rash
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Paresthesia
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Pericardial effusion
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Pericardial tamponade
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Periorbital edema
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Peripheral sensory neuropathy
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Pharyngeal mucositis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Pharyngitis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Platelet count decreased
|
175 Participants
|
168 Participants
|
128 Participants
|
|
Frequency and Severity of Toxicities
Pleural effusion
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Pneumonitis
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Pruritus
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Resp, thoracic and mediastinal disorders - Other
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Respiratory failure
|
3 Participants
|
8 Participants
|
14 Participants
|
|
Frequency and Severity of Toxicities
Restrictive cardiomyopathy
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Salivary duct inflammation
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Scrotal infection
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Scrotal pain
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Skin and subcutaneous tissue disorders - Other
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Skin infection
|
5 Participants
|
1 Participants
|
4 Participants
|
|
Frequency and Severity of Toxicities
Skin ulceration
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Small intestinal obstruction
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Soft tissue infection
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Sore throat
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Stomach pain
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Tumor lysis syndrome
|
4 Participants
|
8 Participants
|
9 Participants
|
|
Frequency and Severity of Toxicities
Typhlitis
|
8 Participants
|
14 Participants
|
23 Participants
|
|
Frequency and Severity of Toxicities
Upper gastrointestinal hemorrhage
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Upper respiratory infection
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Urinary incontinence
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Urinary tract infection
|
5 Participants
|
2 Participants
|
6 Participants
|
|
Frequency and Severity of Toxicities
Urine output decreased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Vaginal hemorrhage
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Vascular access complication
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Vasovagal reaction
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Ventricular tachycardia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Vomiting
|
3 Participants
|
6 Participants
|
4 Participants
|
|
Frequency and Severity of Toxicities
Weight loss
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Anorexia
|
5 Participants
|
16 Participants
|
12 Participants
|
|
Frequency and Severity of Toxicities
Aspartate aminotransferase increased
|
8 Participants
|
15 Participants
|
12 Participants
|
|
Frequency and Severity of Toxicities
Blood and lymphatic system disorders - Other
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Blood bilirubin increased
|
9 Participants
|
15 Participants
|
22 Participants
|
|
Frequency and Severity of Toxicities
Bone infection
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Bone pain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Bronchopulmonary hemorrhage
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Frequency and Severity of Toxicities
Bullous dermatitis
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
CD4 lymphocytes decreased
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Cardiac arrest
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Cardiac disorders - Other, specify
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Cardiac troponin I increased
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Catheter related infection
|
3 Participants
|
7 Participants
|
4 Participants
|
|
Frequency and Severity of Toxicities
Chills
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Chronic kidney disease
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Cognitive disturbance
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Colitis
|
3 Participants
|
9 Participants
|
5 Participants
|
|
Frequency and Severity of Toxicities
Colonic hemorrhage
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Colonic perforation
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Conduction disorder
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Confusion
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Conjunctivitis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Constipation
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Constrictive pericarditis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Creatinine increased
|
1 Participants
|
6 Participants
|
4 Participants
|
|
Frequency and Severity of Toxicities
Death NOS
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Dehydration
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Frequency and Severity of Toxicities
Dental caries
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Device related infection
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Diarrhea
|
15 Participants
|
20 Participants
|
38 Participants
|
|
Frequency and Severity of Toxicities
Disseminated intravascular coagulation
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Dry mouth
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Dry skin
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Dysphagia
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Dyspnea
|
3 Participants
|
7 Participants
|
8 Participants
|
|
Frequency and Severity of Toxicities
Edema cerebral
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Edema limbs
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Ejection fraction decreased
|
2 Participants
|
6 Participants
|
4 Participants
|
|
Frequency and Severity of Toxicities
Electrocardiogram QT corrected interval prolonged
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Encephalopathy
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Enterocolitis
|
1 Participants
|
6 Participants
|
5 Participants
|
|
Frequency and Severity of Toxicities
Enterocolitis infectious
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Frequency and Severity of Toxicities
Epistaxis
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Erythema multiforme
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Erythroderma
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Esophageal hemorrhage
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Esophageal pain
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Esophagitis
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Febrile neutropenia
|
152 Participants
|
160 Participants
|
114 Participants
|
|
Frequency and Severity of Toxicities
Fever
|
4 Participants
|
7 Participants
|
6 Participants
|
|
Frequency and Severity of Toxicities
GGT increased
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Frequency and Severity of Toxicities
Gait disturbance
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Gastric hemorrhage
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Frequency and Severity of Toxicities
Gastritis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Gastroesophageal reflux disease
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Gastrointestinal disorders - Other, specify
|
1 Participants
|
5 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
General disorders and admin site conditions-Other
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Generalized muscle weakness
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Genital edema
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Glucose intolerance
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Gum infection
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Headache
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Frequency and Severity of Toxicities
Heart failure
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Frequency and Severity of Toxicities
Hypomagnesemia
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Hypotension
|
3 Participants
|
12 Participants
|
9 Participants
|
|
Frequency and Severity of Toxicities
Laryngeal mucositis
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Metabolism and nutrition disorders-Other, specify
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Middle ear inflammation
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Oral pain
|
5 Participants
|
5 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Pulmonary edema
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Frequency and Severity of Toxicities
Purpura
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Rash acneiform
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Rash maculo-papular
|
11 Participants
|
26 Participants
|
10 Participants
|
|
Frequency and Severity of Toxicities
Rectal hemorrhage
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Rectal pain
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Renal and urinary disorders - Other, specify
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Seizure
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Sepsis
|
16 Participants
|
26 Participants
|
34 Participants
|
|
Frequency and Severity of Toxicities
Sinus bradycardia
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Sinus tachycardia
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Sinusitis
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Stroke
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Supraventricular tachycardia
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Syncope
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Frequency and Severity of Toxicities
Testicular disorder
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Thromboembolic event
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Thrombotic thrombocytopenic purpura
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Tooth infection
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
White blood cell decreased
|
156 Participants
|
150 Participants
|
112 Participants
|
|
Frequency and Severity of Toxicities
Wound infection
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicities
Abdominal distension
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Abdominal infection
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Abdominal pain
|
4 Participants
|
6 Participants
|
9 Participants
|
|
Frequency and Severity of Toxicities
Acidosis
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Acute kidney injury
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Frequency and Severity of Toxicities
Adult respiratory distress syndrome
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Frequency and Severity of Toxicities
Alanine aminotransferase increased
|
12 Participants
|
17 Participants
|
20 Participants
|
|
Frequency and Severity of Toxicities
Alkaline phosphatase increased
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Alkalosis
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Allergic reaction
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicities
Anal hemorrhage
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicities
Anemia
|
158 Participants
|
164 Participants
|
106 Participants
|
|
Frequency and Severity of Toxicities
Anorectal infection
|
0 Participants
|
0 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Eligible patients with known NPM1 status at baseline
To estimate the prevalence of the mutation NPM1 in this patient population.
Outcome measures
| Measure |
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)
n=467 Participants
INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (High-dose Cytarabine, Idarubicin)
INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)
INDUCTION/RE-INDUCTIONI: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|---|---|
|
Prevalence of the Mutation NPM1 in Patients on This Study.
|
33 percentage of patients
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: There was not sufficient funding to test patients for IDH1, IDH2, TET2, or DMT3A. Therefore, this objective was not completed.
To estimate the prevalence of these mutations in this patient population. This objective will be analyzed as funding allows.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Eligible patients with known cytogenetic risk at baseline
To estimate the cytogenetic risk distribution of patients on this study.
Outcome measures
| Measure |
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)
n=712 Participants
INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (High-dose Cytarabine, Idarubicin)
INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)
INDUCTION/RE-INDUCTIONI: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|---|---|
|
Cytogenetic Risk Distribution of Patients on This Study
High risk
|
22.3 percentage of participants
|
—
|
—
|
|
Cytogenetic Risk Distribution of Patients on This Study
Intermediate risk
|
64.2 percentage of participants
|
—
|
—
|
|
Cytogenetic Risk Distribution of Patients on This Study
Low risk
|
13.5 percentage of participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: OS assessed for up to 5 years, 2 year OS reportedPopulation: Eligible patients
To compare OS between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat. OS is calculated for all patients from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. 2-year OS by arm will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)
n=261 Participants
INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (High-dose Cytarabine, Idarubicin)
n=261 Participants
INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)
n=216 Participants
INDUCTION/RE-INDUCTIONI: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|---|---|
|
Overall Survival (OS)
|
0.56 Proportion of participants
Interval 0.5 to 0.62
|
0.59 Proportion of participants
Interval 0.53 to 0.65
|
0.58 Proportion of participants
Interval 0.5 to 0.64
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsPopulation: Eligible patients
To compare the complete response rate between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat. Complete response is defined as: ANC \>= 1,000/mcl, platelet count \>= 100,000/mcl, \< 5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease (no requirements for marrow cellularity or hemoglobin concentration)
Outcome measures
| Measure |
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)
n=261 Participants
INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (High-dose Cytarabine, Idarubicin)
n=261 Participants
INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)
n=216 Participants
INDUCTION/RE-INDUCTIONI: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|---|---|
|
Complete Response (CR) Rate
|
75 Percentage of participants
Interval 70.0 to 81.0
|
80 Percentage of participants
Interval 74.0 to 84.0
|
77 Percentage of participants
Interval 71.0 to 83.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: DFS assessed for up to 5 years, 2 year DFS reportedPopulation: Eligible patients
To compare the disease-free survival (DFS) between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat. DFS is calculated for patients who have achieved a CR or CRi (complete response with incomplete blood count recovery) . DFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse. 2-year DFS by arm will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)
n=261 Participants
INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Daunorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (High-dose Cytarabine, Idarubicin)
n=261 Participants
INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)
n=216 Participants
INDUCTION/RE-INDUCTIONI: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5.
TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|---|---|
|
Disease-free Survival (DFS)
|
0.48 Proportion of participants
Interval 0.41 to 0.55
|
0.51 Proportion of participants
Interval 0.44 to 0.57
|
0.46 Proportion of participants
Interval 0.38 to 0.54
|
Adverse Events
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)
Serious events: 11 serious events
Other events: 249 other events
Deaths: 126 deaths
Arm II (High-dose Cytarabine, Idarubicin)
Serious events: 27 serious events
Other events: 254 other events
Deaths: 114 deaths
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)
Serious events: 75 serious events
Other events: 206 other events
Deaths: 103 deaths
Serious adverse events
| Measure |
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)
n=261 participants at risk
INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
|
Arm II (High-dose Cytarabine, Idarubicin)
n=259 participants at risk
INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
|
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)
n=211 participants at risk
INDUCTION/RE-INDUCTION: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.38%
1/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.5%
4/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.2%
13/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.77%
2/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.38%
1/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.5%
4/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.4%
3/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Cardiac disorders
Pericardial tamponade
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.39%
1/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.4%
3/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.4%
5/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.8%
6/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.8%
6/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.77%
2/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.39%
1/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.39%
1/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Jejunal obstruction
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.4%
3/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Typhlitis
|
0.38%
1/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
3.3%
7/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.38%
1/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
General disorders
Death NOS
|
0.77%
2/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.39%
1/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
General disorders
Edema limbs
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
General disorders
Edema trunk
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
General disorders
General disorders and admin site conditions - Other
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.39%
1/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
General disorders
Multi-organ failure
|
0.38%
1/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.77%
2/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.9%
4/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
General disorders
Neck edema
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.38%
1/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Hepatobiliary disorders
Hepatobiliary disorders-Other
|
0.38%
1/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Infections and infestations
Infections and infestations-Other
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.4%
5/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Infections and infestations
Lip infection
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Infections and infestations
Lung infection
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.39%
1/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.9%
4/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Infections and infestations
Sepsis
|
0.38%
1/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
4.2%
11/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
8.1%
17/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.8%
6/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.4%
5/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.39%
1/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
3.3%
7/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.39%
1/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Creatinine increased
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.4%
3/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
GGT increased
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
INR increased
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Weight gain
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Weight loss
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.4%
5/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.4%
3/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.38%
1/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.4%
3/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.38%
1/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.9%
4/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.38%
1/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.8%
6/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.38%
1/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.39%
1/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.39%
1/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.9%
4/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.4%
3/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tiss disorder - Other
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Nervous system disorders
Headache
|
0.38%
1/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Nervous system disorders
Nervous system disorders-Other
|
0.38%
1/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.39%
1/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Nervous system disorders
Seizure
|
0.38%
1/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Nervous system disorders
Stroke
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.4%
3/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.77%
2/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.5%
4/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
4.3%
9/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Reproductive system and breast disorders
Genital edema
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.38%
1/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.2%
3/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.9%
4/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.39%
1/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.77%
2/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.4%
5/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.39%
1/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.4%
5/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic and mediastinal disorders - Other
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.39%
1/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
3/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.3%
6/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
7.1%
15/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.47%
1/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Vascular disorders
Hematoma
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.39%
1/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.4%
3/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.77%
2/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
3.8%
8/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.00%
0/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.4%
3/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
Other adverse events
| Measure |
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)
n=261 participants at risk
INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
|
Arm II (High-dose Cytarabine, Idarubicin)
n=259 participants at risk
INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
|
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)
n=211 participants at risk
INDUCTION/RE-INDUCTION: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
70.9%
185/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
71.4%
185/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
64.9%
137/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
60.5%
158/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
65.6%
170/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
56.9%
120/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
4.2%
11/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
3.5%
9/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.7%
12/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
16.9%
44/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
18.1%
47/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
14.2%
30/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
6.1%
16/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.7%
7/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.95%
2/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Eye disorders
Blurred vision
|
5.7%
15/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.0%
13/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
7.6%
16/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Eye disorders
Eye disorders-Other
|
6.1%
16/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.8%
15/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
3.8%
8/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
13/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.7%
7/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.2%
11/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.6%
59/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
35.9%
93/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
36.0%
76/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Bloating
|
4.6%
12/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.2%
16/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
4.3%
9/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Colitis
|
1.9%
5/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.8%
15/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
4.7%
10/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Constipation
|
30.7%
80/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
18.1%
47/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
19.9%
42/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
49.4%
129/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
82.2%
213/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
74.4%
157/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
10.7%
28/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
7.3%
19/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
9.5%
20/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.3%
19/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.4%
14/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
10.4%
22/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
8.0%
21/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.6%
17/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.6%
14/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.1%
16/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.6%
17/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.6%
14/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
5.7%
15/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
7.3%
19/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.2%
11/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.1%
16/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.7%
7/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
8.1%
17/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
36.4%
95/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
35.5%
92/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
31.3%
66/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Nausea
|
55.9%
146/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
69.9%
181/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
69.7%
147/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
5.4%
14/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
0.77%
2/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.8%
6/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Oral pain
|
11.5%
30/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
8.5%
22/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.2%
13/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Typhlitis
|
3.8%
10/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.4%
14/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
8.5%
18/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Gastrointestinal disorders
Vomiting
|
26.4%
69/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
47.9%
124/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
44.1%
93/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
General disorders
Chills
|
18.0%
47/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
17.8%
46/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
17.5%
37/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
General disorders
Edema face
|
4.6%
12/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.0%
13/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
4.3%
9/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
General disorders
Edema limbs
|
27.2%
71/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
34.4%
89/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
21.3%
45/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
General disorders
Fatigue
|
52.9%
138/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
55.2%
143/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
49.8%
105/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
General disorders
Fever
|
29.5%
77/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
32.0%
83/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
26.1%
55/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
General disorders
General disorders and admin site conditions - Other
|
6.1%
16/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
11.2%
29/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
4.3%
9/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
General disorders
Infusion related reaction
|
5.7%
15/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.0%
13/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.8%
6/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
General disorders
Malaise
|
2.7%
7/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.0%
13/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.9%
4/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
General disorders
Non-cardiac chest pain
|
10.0%
26/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
7.7%
20/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
7.6%
16/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
General disorders
Pain
|
10.3%
27/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
13.1%
34/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
8.1%
17/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Infections and infestations
Catheter related infection
|
2.3%
6/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
3.1%
8/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.7%
12/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Infections and infestations
Infections and infestations-Other
|
14.2%
37/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
17.8%
46/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
14.7%
31/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Infections and infestations
Lung infection
|
12.3%
32/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
13.1%
34/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
11.4%
24/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Infections and infestations
Sepsis
|
8.4%
22/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
7.7%
20/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
10.0%
21/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
4.2%
11/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.8%
15/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
4.3%
9/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.2%
11/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
7.3%
19/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.2%
11/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Alanine aminotransferase increased
|
37.9%
99/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
42.1%
109/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
41.2%
87/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Alkaline phosphatase increased
|
26.4%
69/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
27.0%
70/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
31.3%
66/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
34.1%
89/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
41.7%
108/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
44.5%
94/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Blood bilirubin increased
|
26.1%
68/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
34.7%
90/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
34.1%
72/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Creatinine increased
|
7.7%
20/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
12.4%
32/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
16.6%
35/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
INR increased
|
13.8%
36/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
20.5%
53/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
13.7%
29/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Investigations-Other
|
5.0%
13/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
7.7%
20/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.2%
11/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Lymphocyte count decreased
|
37.5%
98/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
43.6%
113/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
39.8%
84/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Neutrophil count decreased
|
59.4%
155/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
53.7%
139/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
53.1%
112/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Platelet count decreased
|
70.9%
185/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
69.5%
180/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
67.3%
142/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
Weight loss
|
15.3%
40/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
14.3%
37/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
19.0%
40/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Investigations
White blood cell decreased
|
62.5%
163/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
59.5%
154/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
57.3%
121/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
31.0%
81/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
39.8%
103/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
39.8%
84/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
35.2%
92/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
37.8%
98/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
42.2%
89/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.7%
15/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
8.1%
21/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.2%
11/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.0%
13/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.6%
17/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.6%
14/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.0%
13/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.2%
16/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
9.0%
19/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
48.7%
127/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
50.2%
130/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
46.9%
99/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
37.9%
99/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
42.1%
109/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
47.4%
100/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.3%
6/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.5%
4/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.2%
11/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
41.8%
109/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
49.0%
127/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
46.4%
98/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
15.7%
41/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
18.9%
49/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
18.5%
39/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
35.6%
93/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
40.9%
106/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
32.2%
68/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
27.2%
71/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
35.1%
91/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
32.7%
69/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.8%
36/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
11.2%
29/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
11.4%
24/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.7%
20/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.8%
15/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
8.5%
18/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.4%
14/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.3%
6/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
3.3%
7/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
26/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
9.7%
25/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
10.4%
22/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Nervous system disorders
Dizziness
|
13.0%
34/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
8.5%
22/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
15.6%
33/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
26/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
14.7%
38/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
14.7%
31/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Nervous system disorders
Headache
|
28.4%
74/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
27.0%
70/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
24.2%
51/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Psychiatric disorders
Anxiety
|
15.7%
41/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
23.9%
62/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
16.6%
35/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Psychiatric disorders
Confusion
|
4.2%
11/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.2%
16/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
4.7%
10/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Psychiatric disorders
Depression
|
7.3%
19/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
10.8%
28/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.6%
14/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Psychiatric disorders
Insomnia
|
18.8%
49/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
19.7%
51/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
18.5%
39/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.4%
9/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
7.3%
19/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
12.3%
26/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Renal and urinary disorders
Hematuria
|
5.4%
14/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.6%
17/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
10.0%
21/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.5%
51/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
18.5%
48/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
19.0%
40/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.1%
55/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
20.8%
54/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
19.0%
40/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.4%
35/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
14.3%
37/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
12.8%
27/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.9%
5/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.4%
14/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
7.6%
16/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
10/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.9%
18/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.2%
13/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
20/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.4%
14/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.7%
12/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.1%
16/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.6%
17/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
9.0%
19/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.8%
10/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.9%
18/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
4.3%
9/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
4.2%
11/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.8%
15/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
3.8%
8/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic and mediastinal disorders - Other
|
2.7%
7/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
7.7%
20/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
4.7%
10/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
13.0%
34/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
6.9%
18/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
8.5%
18/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.6%
46/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
15.8%
41/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
21.8%
46/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.1%
16/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
11.2%
29/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
10.4%
22/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.1%
8/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.0%
13/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.9%
4/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
2.3%
6/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.4%
14/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
1.4%
3/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.6%
38/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
22.4%
58/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
19.9%
42/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
4.2%
11/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.8%
15/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
2.8%
6/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.2%
11/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
5.0%
13/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
4.3%
9/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
36.0%
94/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
45.2%
117/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
38.9%
82/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
11.1%
29/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
15.1%
39/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
11.8%
25/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Vascular disorders
Hypertension
|
14.6%
38/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
20.8%
54/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
12.8%
27/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
|
Vascular disorders
Hypotension
|
14.9%
39/261 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
17.4%
45/259 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
13.3%
28/211 • Up to 5 years
Number of patients with adverse events are reported by type of adverse event. All adverse events, regardless of attribution or grade, are reported. Adverse events are reported for eligible patients who started treatment.
|
Additional Information
Leukemia Committee Statistician
SWOG Statistics and Data Management Center
Phone: 206-667-4623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place