Trial Outcomes & Findings for Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (NCT NCT03092674)
NCT ID: NCT03092674
Last Updated: 2025-01-16
Results Overview
Time from date of randomization on study until death from any cause with observations censored on the day of last contact for patients not known to have died.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
76 participants
Primary outcome timeframe
Day of registration on study until death from any cause, assessed for up to 5 years
Results posted on
2025-01-16
Participant Flow
78 participants were initially randomized to the study, 26 per arm. Two were ineligible, one on the Azacitidine+Nivolumab arm and one in the Azacitidine+Midostaurin arm. 76 participants were eligible and included in the primary analysis (26 in the Azacitidine arm, 25 in the Azacitidine+Nivolumab arm, and 25 in the Azacitidine+Midostaurin arm).
Participant milestones
| Measure |
Azacitidine
Patients receive azacitidine SC or IV daily on days 1-7 or on an interrupted schedule which ensures that all 7 days of therapy are received within a 12 day period. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine + Nivolumab
Patients receive azacitidine as in Arm A and nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine + Midostaurin
Patients receive azacitidine as in Arm A and midostaurin orally (PO) twice daily (BID) on days 8-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
25
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
26
|
25
|
25
|
Reasons for withdrawal
| Measure |
Azacitidine
Patients receive azacitidine SC or IV daily on days 1-7 or on an interrupted schedule which ensures that all 7 days of therapy are received within a 12 day period. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine + Nivolumab
Patients receive azacitidine as in Arm A and nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine + Midostaurin
Patients receive azacitidine as in Arm A and midostaurin orally (PO) twice daily (BID) on days 8-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
Adverse Event or Side Effects
|
1
|
4
|
4
|
|
Overall Study
Refusal Unrelated to Adverse Event
|
5
|
1
|
3
|
|
Overall Study
Progression/Relapse
|
5
|
4
|
8
|
|
Overall Study
Death
|
4
|
8
|
2
|
|
Overall Study
Other - Not Protocol Specified
|
11
|
8
|
8
|
Baseline Characteristics
Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Baseline characteristics by cohort
| Measure |
Azacitidine
n=26 Participants
Patients receive azacitidine SC or IV daily on days 1-7 or on an interrupted schedule which ensures that all 7 days of therapy are received within a 12 day period. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine + Nivolumab
n=25 Participants
Patients receive azacitidine as in Arm A and nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine +Midostaurin
n=25 Participants
Patients receive azacitidine as in Arm A and midostaurin orally (PO) twice daily (BID) on days 8-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
75.5 years
n=5 Participants
|
76.4 years
n=7 Participants
|
76.2 years
n=5 Participants
|
75.6 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Baseline Blast Percentage
<20% (MDS-EB-2)
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Baseline Blast Percentage
>=20% (AML)
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
FLT3-Centrally Reviewed
Wild Type FLT3-ITD
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
FLT3-Centrally Reviewed
Mutated FLT3-ITD
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Zubrod Performance Status
0-1
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Zubrod Performance Status
2-4
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day of registration on study until death from any cause, assessed for up to 5 yearsPopulation: The analysis population includes the 76 participants who were eligible and evaluable (26 in the Azacitidine arm, 25 in the Azacitidine+Nivolumab arm, and 25 in the Azacitidine+Midostaurin arm).
Time from date of randomization on study until death from any cause with observations censored on the day of last contact for patients not known to have died.
Outcome measures
| Measure |
Azacitidine
n=26 Participants
Patients receive azacitidine SC or IV daily on days 1-7 or on an interrupted schedule which ensures that all 7 days of therapy are received within a 12 day period. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine + Nivolumab
n=25 Participants
Patients receive azacitidine as in Arm A and nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine +Midostaurin
n=25 Participants
Patients receive azacitidine as in Arm A and midostaurin orally (PO) twice daily (BID) on days 8-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Survival (OS) (Phase II)
|
6.2 months
Interval 3.9 to 10.0
|
5.2 months
Interval 1.1 to 13.1
|
7.4 months
Interval 2.9 to 16.4
|
PRIMARY outcome
Timeframe: Day of registration on study until death from any cause, assessed for up to 5 yearsPopulation: Due to unexpected toxicities on the Azacitidine + Nivolumab arm during the first two cycles of therapy, the trial was closed early, before the phase II portions was completed and before reaching the phase III portion.
Time from date of randomization on study until death from any cause with observations censored on the day of last contact for patients not known to have died.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).Population: Participants who were eligible and received at least one dose of protocol treatment.
Only adverse events that are possibly, probably, or definitely related to study drugs are reported. CTCAE Version 5.0 was used for all AE reporting.
Outcome measures
| Measure |
Azacitidine
n=25 Participants
Patients receive azacitidine SC or IV daily on days 1-7 or on an interrupted schedule which ensures that all 7 days of therapy are received within a 12 day period. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine + Nivolumab
n=25 Participants
Patients receive azacitidine as in Arm A and nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine +Midostaurin
n=23 Participants
Patients receive azacitidine as in Arm A and midostaurin orally (PO) twice daily (BID) on days 8-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Electrocardiogram QT corrected interval prolonged
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Epistaxis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Febrile neutropenia
|
10 Participants
|
7 Participants
|
8 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fever
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Acute kidney injury
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Heart failure
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperglycemia
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypokalemia
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash maculo-papular
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Respiratory failure
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Small intestinal perforation
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sudden death NOS
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspnea
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
White blood cell decreased
|
12 Participants
|
10 Participants
|
16 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ejection fraction decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Acidosis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alanine aminotransferase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anemia
|
12 Participants
|
10 Participants
|
13 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anorexia
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Arthralgia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Aspartate aminotransferase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Atrial fibrillation
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Back pain
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Blood and lymphatic system disorders - Other, spec
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac troponin I increased
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Catheter related infection
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Chest pain - cardiac
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Colitis
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Constipation
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dry mouth
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gastrointestinal disorders - Other, specify
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Generalized muscle weakness
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypertension
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypoalbuminemia
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyponatremia
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypophosphatemia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypotension
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypoxia
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
INR increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Immune system disorders - Other, specify
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infections and infestations - Other, specify
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Joint infection
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lung infection
|
2 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphocyte count decreased
|
3 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis oral
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neutrophil count decreased
|
10 Participants
|
10 Participants
|
15 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Platelet count decreased
|
11 Participants
|
9 Participants
|
10 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pneumonitis
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pruritus
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pulmonary edema
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sepsis
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Skin infection
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Supraventricular tachycardia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Typhlitis
|
0 Participants
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsPopulation: The analysis population includes the 76 participants who were eligible and evaluable (26 in the Azacitidine arm, 25 in the Azacitidine+Nivolumab arm, and 25 in the Azacitidine+Midostaurin arm).
#participants(ps) w comp response(resp)(CR), comp remission w incomp bld ct recovery(CRp/CRi), morphol leukemia-free state(MLFS), erythroid\&neutrophil\&platelet resp(HI-E,HI-N,HI-P), HI-P, marrow comp resp(CRm), stable disease(SD), no resp(NR) CR:BM blasts\<5%; no circ blasts\&blasts w Auer rods(AR); no extramedullary disease(ED); ANC≥1x10\^9/L; plt ct≥100x10\^9/L CRp/CRi:CR criteria excl residual neutropenia\<1x10\^9/L or ITP\<100x10\^9/L MLFS:BM blasts\<5%; no blasts w AR, ED, hem recovery rqd HI-E:≥1.5g/dL↑Hb pretx;\&RBC trans-depen ps, achieve trans independ or relevant↓RBC trans rqd HI-N:ANC↑pretx≥100%,\&an absolute↑of\>500/mm3 pretx HI-P:Absolute↑≥30000/mm3 pretx for ps w plt ct\>20000/mm3 pretx. Ps w plt ct≤20000/mm3 pretx,↑≥100% pretx ct to plt ct\>20000/mm3. Plt trans-depend ps, plt trans independ rqd CRm:CR for BM exam≤5%myeloblasts\&marrow myeloblasts↓≥50%pretx SD:Not achieve≥PR, w no evidence prog NR:Not achieve CR,CRi,PR,MLFS,SD, excl ps w death in aplasia or due to indet cause
Outcome measures
| Measure |
Azacitidine
n=26 Participants
Patients receive azacitidine SC or IV daily on days 1-7 or on an interrupted schedule which ensures that all 7 days of therapy are received within a 12 day period. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine + Nivolumab
n=25 Participants
Patients receive azacitidine as in Arm A and nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine +Midostaurin
n=25 Participants
Patients receive azacitidine as in Arm A and midostaurin orally (PO) twice daily (BID) on days 8-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Remission Rates
Complete Response
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Remission Rates
CRp/CRi
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Remission Rates
MLFS
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Remission Rates
HI-E and HI-N and HI-P
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Remission Rates
HI-P only
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Remission Rates
CRm
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Remission Rates
Stable disease
|
8 Participants
|
6 Participants
|
7 Participants
|
|
Remission Rates
No response
|
10 Participants
|
13 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day of registration on study until death from any cause, assessed for up to 5 yearsWill be estimated using the Kaplan-Meier method or Cox regression models. Landmark analyses of different response categories will be evaluated based on dates at which 75% and 90% of patients have achieved a response (with other quantiles analyzed as needed).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Date of achievement of a remission until the date of relapse or death from any cause, assessed for up to 5 yearsPopulation: The analysis population includes the 17 participants who were eligible and evaluable and had complete response or complete remission with incomplete blood count recovery (CRp/CRi) (6 in the Azacitidine arm, 5 in the Azacitidine+Nivolumab arm, and 6 in the Azacitidine+Midostaurin arm).
Time from the date of achievement of a remission (defined as patients achieving complete remission (CR), or CR with incomplete hematological recovery (CRi)) until the date of relapse or death from any cause; patients not known to have relapsed or died at last follow-up are censored on the date of last contact.
Outcome measures
| Measure |
Azacitidine
n=6 Participants
Patients receive azacitidine SC or IV daily on days 1-7 or on an interrupted schedule which ensures that all 7 days of therapy are received within a 12 day period. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine + Nivolumab
n=5 Participants
Patients receive azacitidine as in Arm A and nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine +Midostaurin
n=6 Participants
Patients receive azacitidine as in Arm A and midostaurin orally (PO) twice daily (BID) on days 8-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Relapse-free Survival (RFS)
|
3.5 months
Interval 0.6 to 13.3
|
9.4 months
Interval 1.5 to 17.1
|
13.3 months
Interval 4.0 to 26.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date of randomization to the first of: date of primary refractory disease; date of progressive disease; date off protocol therapy without CR or CRi; date of relapse from CR or CRi, or death from any cause, assessed for up to 5 yearsPopulation: The analysis population includes the 76 participants who were eligible and evaluable (26 in the Azacitidine arm, 25 in the Azacitidine+Nivolumab arm, and 25 in the Azacitidine+Midostaurin arm).
Time from from the date of randomization to the first of: date of primary refractory disease; date of progressive disease; date off protocol therapy without CR or CRi; date of relapse from CR or CRi, or death from any cause; patients not known to have any of these events are censored on the date of last contact.
Outcome measures
| Measure |
Azacitidine
n=26 Participants
Patients receive azacitidine SC or IV daily on days 1-7 or on an interrupted schedule which ensures that all 7 days of therapy are received within a 12 day period. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine + Nivolumab
n=25 Participants
Patients receive azacitidine as in Arm A and nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine +Midostaurin
n=25 Participants
Patients receive azacitidine as in Arm A and midostaurin orally (PO) twice daily (BID) on days 8-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Event-free Survival (EFS)
|
3.6 months
Interval 1.1 to 4.1
|
1.8 months
Interval 0.6 to 2.7
|
4.5 months
Interval 1.8 to 9.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date of achievement of a remission until the date of relapse or death, assessed for up to 5 yearsCumulative incident endpoints and associations will be assessed using Cox regression models (for cause-specific hazards as appropriate).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsThe prognostic effect of FLT3-ITD (positive versus negative or non-evaluable) with respect to the outcome OS will be evaluated using Cox regression models. The predictive effect of FLT3-ITD (positive versus negative/non-evaluable) with respect to the outcome of OS and the treatments of azacitdine+midostaurin versus azacitidine will be evaluated using a Cox regression model with treatment arm and FLT3-ITD as covariates and including the interaction between the two covariates.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsUnivariate and multivariable regression models will be used to assess potential associations between outcomes (CR, OS, EFS, and RFS) and cytogenetic abnormalities and mutation status (including FLT3-ITD). Regression models including interaction terms with treatment arm will be fit. In addition to analyzing FLT3-ITD as categorical variable used in randomization stratification, we will analyze FLT3-TKD also and evaluate FLT3-ITD allelic ratio as a quantitative variable and as a binary variable using the threshold of 0.50.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsOnly concurrently randomized patients will be evaluated in comparisons between arms.
Outcome measures
Outcome data not reported
Adverse Events
Azacitidine
Serious events: 9 serious events
Other events: 23 other events
Deaths: 24 deaths
Azacitidine + Nivolumab
Serious events: 20 serious events
Other events: 23 other events
Deaths: 25 deaths
Azacitidine +Midostaurin
Serious events: 17 serious events
Other events: 22 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Azacitidine
n=25 participants at risk
Patients receive azacitidine SC or IV daily on days 1-7 or on an interrupted schedule which ensures that all 7 days of therapy are received within a 12 day period. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. One participant withdrew from protocol therapy before starting treatment and is therefore included in the All-Cause Mortality but not Serious Adverse Events.
|
Azacitidine + Nivolumab
n=25 participants at risk
Patients receive azacitidine as in Arm A and nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine +Midostaurin
n=23 participants at risk
Patients receive azacitidine as in Arm A and midostaurin orally (PO) twice daily (BID) on days 8-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. One participant withdrew from protocol therapy before starting treatment and one participant died before starting treatment, therefore these two participants are included in the All-Cause Mortality but not Serious Adverse Events.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
20.0%
5/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
32.0%
8/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
26.1%
6/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
17.4%
4/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Cardiac disorders
Pericardial tamponade
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Cardiac disorders
Supraventricular tachycardia
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Jejunal obstruction
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Chills
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Death NOS
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Edema limbs
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Fatigue
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Fever
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Infusion related reaction
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Multi-organ failure
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Pain
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Sudden death NOS
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Immune system disorders
Immune system disorders-Other
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Infections and infestations
Infections and infestations-Other
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Infections and infestations
Joint infection
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Infections and infestations
Lung infection
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
20.0%
5/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
21.7%
5/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Infections and infestations
Sepsis
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
28.0%
7/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Infections and infestations
Skin infection
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Cardiac troponin I increased
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
13.0%
3/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Platelet count decreased
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
20.0%
5/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
White blood cell decreased
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
13.0%
3/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Acidosis
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Nervous system disorders
Intracranial hemorrhage
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Nervous system disorders
Seizure
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Psychiatric disorders
Delirium
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Vascular disorders
Hypertension
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Vascular disorders
Hypotension
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Vascular disorders
Thromboembolic event
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
Other adverse events
| Measure |
Azacitidine
n=25 participants at risk
Patients receive azacitidine SC or IV daily on days 1-7 or on an interrupted schedule which ensures that all 7 days of therapy are received within a 12 day period. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. One participant withdrew from protocol therapy before starting treatment and is therefore included in the All-Cause Mortality but not Serious Adverse Events.
|
Azacitidine + Nivolumab
n=25 participants at risk
Patients receive azacitidine as in Arm A and nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Azacitidine +Midostaurin
n=23 participants at risk
Patients receive azacitidine as in Arm A and midostaurin orally (PO) twice daily (BID) on days 8-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. One participant withdrew from protocol therapy before starting treatment and one participant died before starting treatment, therefore these two participants are included in the All-Cause Mortality but not Serious Adverse Events.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
21.7%
5/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
56.0%
14/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
36.0%
9/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
43.5%
10/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
24.0%
6/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
32.0%
8/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
30.4%
7/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
21.7%
5/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
30.4%
7/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
34.8%
8/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
17.4%
4/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
34.8%
8/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Blood and lymphatic system disorders
Anemia
|
52.0%
13/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
48.0%
12/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
56.5%
13/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders-Other
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
28.0%
7/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
26.1%
6/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Cardiac disorders
Cardiac disorders-Other
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
13.0%
3/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Cardiac disorders
Heart failure
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Cardiac disorders
Myocardial infarction
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Cardiac disorders
Sinus tachycardia
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Eye disorders
Blurred vision
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Eye disorders
Eye disorders-Other
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
26.1%
6/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Constipation
|
52.0%
13/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
28.0%
7/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
73.9%
17/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Diarrhea
|
24.0%
6/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
20.0%
5/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
39.1%
9/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
17.4%
4/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
17.4%
4/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Flatulence
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Mucositis oral
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
13.0%
3/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Nausea
|
36.0%
9/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
24.0%
6/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
52.2%
12/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Oral pain
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Gastrointestinal disorders
Vomiting
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
47.8%
11/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Chills
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
17.4%
4/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Edema limbs
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
21.7%
5/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Fatigue
|
48.0%
12/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
32.0%
8/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
65.2%
15/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Fever
|
20.0%
5/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Gait disturbance
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
General disorders and administration site conditio
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Injection site reaction
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Malaise
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Non-cardiac chest pain
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
17.4%
4/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
General disorders
Pain
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
34.8%
8/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Infections and infestations
Infections and infestations-Other
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
13.0%
3/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Infections and infestations
Lung infection
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Infections and infestations
Sinusitis
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Infections and infestations
Skin infection
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Infections and infestations
Urinary tract infection
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
13.0%
3/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Injury, poisoning and procedural complications
Bruising
|
24.0%
6/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
30.4%
7/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
17.4%
4/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications-Oth
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Alanine aminotransferase increased
|
32.0%
8/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
20.0%
5/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
30.4%
7/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Alkaline phosphatase increased
|
24.0%
6/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
39.1%
9/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
32.0%
8/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
28.0%
7/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
30.4%
7/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Blood bilirubin increased
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
34.8%
8/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Cardiac troponin I increased
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Creatinine increased
|
24.0%
6/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
40.0%
10/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
43.5%
10/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
17.4%
4/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
INR increased
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Lymphocyte count decreased
|
36.0%
9/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
44.0%
11/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
39.1%
9/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Neutrophil count decreased
|
48.0%
12/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
40.0%
10/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
56.5%
13/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Platelet count decreased
|
48.0%
12/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
44.0%
11/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
56.5%
13/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Serum amylase increased
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
Weight loss
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
30.4%
7/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Investigations
White blood cell decreased
|
72.0%
18/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
52.0%
13/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
65.2%
15/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
48.0%
12/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
43.5%
10/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
36.0%
9/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
39.1%
9/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
20.0%
5/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
17.4%
4/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
13.0%
3/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
36.0%
9/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
44.0%
11/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
56.5%
13/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
17.4%
4/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
28.0%
7/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
39.1%
9/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Nervous system disorders
Dizziness
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
26.1%
6/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
17.4%
4/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
26.1%
6/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
21.7%
5/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Psychiatric disorders
Depression
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
21.7%
5/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Psychiatric disorders
Insomnia
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
21.7%
5/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Renal and urinary disorders
Hematuria
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
13.0%
3/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
13.0%
3/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
20.0%
5/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
39.1%
9/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
24.0%
6/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
20.0%
5/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
39.1%
9/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
17.4%
4/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
17.4%
4/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders-Ot
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.0%
1/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
13.0%
3/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
13.0%
3/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
13.0%
3/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
24.0%
6/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
13.0%
3/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders-Other
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
26.1%
6/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
8.7%
2/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Vascular disorders
Hypertension
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
16.0%
4/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
17.4%
4/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Vascular disorders
Hypotension
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
12.0%
3/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
30.4%
7/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
|
Vascular disorders
Thromboembolic event
|
8.0%
2/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
0.00%
0/25 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
4.3%
1/23 • Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2).
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 25 participants in the Azacitidine arm, 25 participants in the Azacitidine + Nivolumab arm, and 23 participants in the Azacitidine + Midostaurin arm that were evaluable for AEs.
|
Additional Information
Leukemia Committee Statistician
SWOG Statistics and Data Management Center
Phone: 2066674623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60