Trial Outcomes & Findings for A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy (NCT NCT02752035)
NCT ID: NCT02752035
Last Updated: 2025-09-12
Results Overview
OS was defined as the time from the date of randomization until the date of death from any cause. For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact. Kaplan-Meier (KM) estimates was used for analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
183 participants
Primary outcome timeframe
From the date of randomization until the date of death from any cause ( maximum duration up to 79 months)
Results posted on
2025-09-12
Participant Flow
Participants with newly diagnosed, FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML) not eligible for intensive induction were enrolled.
Prior to randomized cohort, participants were enrolled for safety cohort to evaluate safety and tolerability of gilteritinib given with azacitidine therapy.
Participant milestones
| Measure |
Safety Cohort: Gilteritinib + Azacitidine (AZA)
Participants received 80 mg (2 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles and 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle. Depending on the safety cohort data ,the decision to initiate the randomized trial at the targeted dose was made. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib + AZA
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
Safety Cohort: Approximately 5 Years
STARTED
|
15
|
0
|
0
|
0
|
|
Safety Cohort: Approximately 5 Years
COMPLETED
|
0
|
0
|
0
|
0
|
|
Safety Cohort: Approximately 5 Years
NOT COMPLETED
|
15
|
0
|
0
|
0
|
|
Randomization: Approximately 3 Years
STARTED
|
0
|
89
|
57
|
22
|
|
Randomization: Approximately 3 Years
COMPLETED
|
0
|
0
|
0
|
0
|
|
Randomization: Approximately 3 Years
NOT COMPLETED
|
0
|
89
|
57
|
22
|
|
Long-term Follow-up: up to 3 Years
STARTED
|
5
|
33
|
34
|
10
|
|
Long-term Follow-up: up to 3 Years
COMPLETED
|
0
|
0
|
0
|
0
|
|
Long-term Follow-up: up to 3 Years
NOT COMPLETED
|
5
|
33
|
34
|
10
|
Reasons for withdrawal
| Measure |
Safety Cohort: Gilteritinib + Azacitidine (AZA)
Participants received 80 mg (2 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles and 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle. Depending on the safety cohort data ,the decision to initiate the randomized trial at the targeted dose was made. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib + AZA
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
Safety Cohort: Approximately 5 Years
Miscellaneous
|
2
|
0
|
0
|
0
|
|
Safety Cohort: Approximately 5 Years
Disease relapse
|
5
|
0
|
0
|
0
|
|
Safety Cohort: Approximately 5 Years
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Safety Cohort: Approximately 5 Years
Lack of Efficacy
|
1
|
0
|
0
|
0
|
|
Safety Cohort: Approximately 5 Years
Death
|
5
|
0
|
0
|
0
|
|
Safety Cohort: Approximately 5 Years
Adverse Event
|
1
|
0
|
0
|
0
|
|
Randomization: Approximately 3 Years
Miscellaneous
|
0
|
7
|
4
|
1
|
|
Randomization: Approximately 3 Years
Disease Relapse
|
0
|
22
|
16
|
6
|
|
Randomization: Approximately 3 Years
Physician Decision
|
0
|
3
|
1
|
1
|
|
Randomization: Approximately 3 Years
Withdrawal by Subject
|
0
|
14
|
7
|
4
|
|
Randomization: Approximately 3 Years
Lack of Efficacy
|
0
|
4
|
14
|
0
|
|
Randomization: Approximately 3 Years
Death
|
0
|
25
|
13
|
4
|
|
Randomization: Approximately 3 Years
Adverse Event
|
0
|
14
|
2
|
6
|
|
Long-term Follow-up: up to 3 Years
Withdrawal by Subject
|
0
|
3
|
3
|
0
|
|
Long-term Follow-up: up to 3 Years
Lost to Follow-up
|
0
|
1
|
1
|
0
|
|
Long-term Follow-up: up to 3 Years
Death
|
5
|
26
|
30
|
10
|
|
Long-term Follow-up: up to 3 Years
Miscellaneous
|
0
|
3
|
0
|
0
|
Baseline Characteristics
A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy
Baseline characteristics by cohort
| Measure |
Safety Cohort: Gilteritinib + Azacitidine (AZA)
n=15 Participants
Participants received 80 mg (2 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles and 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle. Depending on the safety cohort data ,the decision to initiate the randomized trial at the targeted dose was made. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib + AZA
n=89 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
n=57 Participants
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
n=22 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
75.3 Years
STANDARD_DEVIATION 5.6 • n=93 Participants
|
77.1 Years
STANDARD_DEVIATION 5.7 • n=4 Participants
|
76.9 Years
STANDARD_DEVIATION 5.2 • n=27 Participants
|
78.5 Years
STANDARD_DEVIATION 4.2 • n=483 Participants
|
77.1 Years
STANDARD_DEVIATION 5.4 • n=36 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
85 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
98 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
153 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
11 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
106 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
53 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
1 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Age group per Interactive Response Technology (IRT)
< 75 years
|
6 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
52 Participants
n=36 Participants
|
|
Age group per Interactive Response Technology (IRT)
>= 75 years
|
9 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
131 Participants
n=36 Participants
|
|
FMS-like tyrosine kinase 3 (FLT3) mutation type
Internal Tandem Duplication (ITD) Alone
|
10 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
143 Participants
n=36 Participants
|
|
FMS-like tyrosine kinase 3 (FLT3) mutation type
Tyrosine Kinase Domain (TKD) (D835/I836) Alone
|
3 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
30 Participants
n=36 Participants
|
|
FMS-like tyrosine kinase 3 (FLT3) mutation type
ITD with TKD (D835/I836)
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
FMS-like tyrosine kinase 3 (FLT3) mutation type
Others (unknown/missing/negative)
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Cytogenetic risk status
Favorable
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Cytogenetic risk status
Intermediate
|
11 Participants
n=93 Participants
|
63 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
131 Participants
n=36 Participants
|
|
Cytogenetic risk status
Unfavorable
|
1 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
|
Cytogenetic risk status
Others (unknown, missing)
|
3 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
34 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization until the date of death from any cause ( maximum duration up to 79 months)Population: The full analysis set (FAS) was defined as the intention to treat set, which consisted of participants who were randomized and were used for efficacy analyses.
OS was defined as the time from the date of randomization until the date of death from any cause. For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact. Kaplan-Meier (KM) estimates was used for analysis.
Outcome measures
| Measure |
Randomized Cohort: Gilteritinib + AZA
n=89 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
n=57 Participants
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
n=22 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
Randomized Cohort: Gilteritinib
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
9.82 months
Interval 8.11 to 13.17
|
9.23 months
Interval 4.34 to 12.55
|
5.24 months
Interval 2.46 to 15.18
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization until the date of documented relapse from CR, treatment failure or death from any cause, whichever occurred first (up to 39.7 months)Population: FAS population
EFS: time from the date of randomization until the date of documented relapse from Complete Remission (CR), treatment failure(failing to achieve CR within 6 cycles of treatment) or death from any cause, whichever occurred first. CR: bone marrow(BM) regenerating normal hematopoietic cells, morphologically leukemia-free state, absolute neutrophil count (ANC) ≥1 × 10\^9/L, platelet count ≥100 × 10\^9/L, normal marrow differential with \<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being red blood cell (RBC) and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. Relapse: reappearance of leukemic blasts \>2% in the peripheral blood/≥ 5% myeloblasts in the BM unattributable to any other cause/new/reappearance of extramedullary leukemia.
Outcome measures
| Measure |
Randomized Cohort: Gilteritinib + AZA
n=89 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
n=57 Participants
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
n=22 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
Randomized Cohort: Gilteritinib
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
Event-free Survival (EFS)
|
0.03 months
Lower and upper limits of the 95% confidence interval were not estimable due to insufficient number of participants with events.
|
0.03 months
Lower and upper limits of the 95% confidence interval were not estimable due to insufficient number of participants with events.
|
0.03 months
Interval 0.03 to 2.46
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization until the date of death from any cause (up to 57 months)Population: FAS population
Best response for a participant was defined as the best measured response (in the order of CR, CR with Incomplete Platelet Recovery (CRp), CR with Incomplete Hematologic Recovery (CRi), and treatment failure) from all post-baseline visits. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\^9/L, platelet count ≥100 × 10\^9/L, normal marrow differential with \<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRp: achieved CR except incomplete platelet recovery (\< 100 × 10\^9/L). CRi: achieved CR except incomplete hematological recovery with residual neutropenia \< 1 x 10\^9/L with or without complete platelet recovery. RBC and platelet transfusion independence not required.
Outcome measures
| Measure |
Randomized Cohort: Gilteritinib + AZA
n=89 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
n=57 Participants
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
n=22 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
Randomized Cohort: Gilteritinib
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
Percentage of Participants With Best Response
CR
|
25.8 percentage of participants
|
17.5 percentage of participants
|
9.1 percentage of participants
|
—
|
|
Percentage of Participants With Best Response
CRp
|
6.7 percentage of participants
|
0 percentage of participants
|
18.2 percentage of participants
|
—
|
|
Percentage of Participants With Best Response
CRi
|
29.2 percentage of participants
|
10.5 percentage of participants
|
27.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization until the date of death from any cause (approximately 49.7 months)Population: FAS population
CR rate: number of participants who achieved the best response of CR divided by the number of participants in the analysis population. Participants with unknown or missing response, or who provided no information on response at the end of treatment were included in the denominator when calculating rates. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\^9/L, platelet count ≥100 × 10\^9/L, normal marrow differential with \<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent(1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods.
Outcome measures
| Measure |
Randomized Cohort: Gilteritinib + AZA
n=89 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
n=57 Participants
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
n=22 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
Randomized Cohort: Gilteritinib
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
Completed Remission (CR) Rate
|
25.8 percentage of participants
|
17.5 percentage of participants
|
9.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization until the date of death from any cause (approximately 54.5 months)Population: FAS population
CRc rate was defined as participants with best response of (CR + CRp + CRi) divided by the number of participants in the analysis population. Participants were classified as: CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\^9/L, platelet count ≥100 × 10\^9/L, normal marrow differential with \<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRp: achieved CR except incomplete platelet recovery (\< 100 × 10\^9/L). CRi: achieved CR except incomplete hematological recovery with residual neutropenia \< 1 x 10\^9/L with or without complete platelet recovery. RBC and platelet transfusion independence not required. Percentage of participants with CRc was reported.
Outcome measures
| Measure |
Randomized Cohort: Gilteritinib + AZA
n=89 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
n=57 Participants
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
n=22 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
Randomized Cohort: Gilteritinib
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
CRc Rate
|
61.8 percentage of participants
|
28.1 percentage of participants
|
54.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization until the date of death from any cause (up to 49.7 months)Population: FAS population
CRh was defined as the response at a post baseline visit as CRh having bone marrow myeloblast count \< 5%, partial hematologic recovery ANC ≥ 0.5 x 10\^9/L and platelets ≥ 50 x 10\^9/L, no evidence of extramedullary leukemia and cannot be classified as CR. The blast counts in peripheral blood must be ≤ 2% or missing. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\^9/L, platelet count ≥100 × 10\^9/L, normal marrow differential with \<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. Percentage of participants with CRh was reported.
Outcome measures
| Measure |
Randomized Cohort: Gilteritinib + AZA
n=89 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
n=57 Participants
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
n=22 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
Randomized Cohort: Gilteritinib
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
Complete Remission With Partial Hematologic Recovery (CRh)
|
10.1 percentage of participants
|
1.8 percentage of participants
|
22.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization until the date of death from any cause (up to 49.7 months)Population: FAS population
CR/CRh rate: number of participants who achieved CR or CRh divided by the number of participants in the analysis population. CR/CRh: CR/CRh if it fulfilled criteria for CR or CRh at the visit. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\^9/L, platelet count ≥100 × 10\^9/L, normal marrow differential with \<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRh: response at a post baseline visit as CRh having bone marrow myeloblast count \< 5%, partial hematologic recovery ANC ≥ 0.5 x 10\^9/L and platelets ≥ 50 x 10\^9/L, no evidence of extramedullary leukemia and cannot be classified as CR. The blast counts in peripheral blood must be ≤ 2% or missing. Percentage of participants with CR/CRh was reported.
Outcome measures
| Measure |
Randomized Cohort: Gilteritinib + AZA
n=89 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
n=57 Participants
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
n=22 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
Randomized Cohort: Gilteritinib
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
CR/CRh Rate
|
36.0 percentage of participants
|
19.3 percentage of participants
|
31.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From baseline up to 57 monthsPopulation: FAS population included participants who were transfusion dependent at baseline period.
Transfusion conversion rate was defined as the number of participants who were transfusion dependent at baseline period but became transfusion independent at post-baseline period divided by the total number of participants who were transfusion dependent at baseline period.
Outcome measures
| Measure |
Randomized Cohort: Gilteritinib + AZA
n=73 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
n=38 Participants
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
n=18 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
Randomized Cohort: Gilteritinib
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
Percentage of Participants With Transfusion Conversion Rate
|
35.6 percentage of participants
Interval 24.7 to 47.7
|
44.7 percentage of participants
Interval 28.6 to 61.7
|
61.1 percentage of participants
Interval 35.7 to 82.7
|
—
|
SECONDARY outcome
Timeframe: From baseline up to 57 monthsPopulation: FAS population included participants who were transfusion independent at baseline period.
Transfusion maintenance rate was defined as the number of participants who were transfusion independent at baseline period and remained transfusion independent post-baseline period divided by the total number of participants who were transfusion independent at baseline period.
Outcome measures
| Measure |
Randomized Cohort: Gilteritinib + AZA
n=3 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
n=2 Participants
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
n=2 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
Randomized Cohort: Gilteritinib
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
Percentage of Participants With Transfusion Maintenance Rate
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
—
|
SECONDARY outcome
Timeframe: From first day of achieving first CRc to the first day of confirmed relapse/death (up to 54.5 months)Population: FAS population included participants who had achieved CRc.
LFS: time from the date of first CRc (CR + CRp + CRi) until the date of documented relapse (excluding relapse from PR) or death for participants who achieved CRc. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\^9/L, platelet count ≥100 × 10\^9/L, normal marrow differential with \<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRp: achieved CR except incomplete platelet recovery (\< 100 × 10\^9/L). CRi: achieved CR except incomplete hematological recovery with residual neutropenia \< 1 x 10\^9/L with or without complete platelet recovery. RBC and platelet transfusion independence not required. CRc: fulfilled criteria for CR, CRp or CRi. Based on KM estimates.
Outcome measures
| Measure |
Randomized Cohort: Gilteritinib + AZA
n=55 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
n=16 Participants
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
n=12 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
Randomized Cohort: Gilteritinib
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
Leukemia-free Survival (LFS)
|
7.16 months
Interval 6.01 to 12.52
|
8.08 months
Interval 2.46 to 14.09
|
3.20 months
Interval 0.89 to 6.87
|
—
|
SECONDARY outcome
Timeframe: From first day of achieving first response to the first day of confirmed relapse/death (up to 56.4 months)Population: FAS population with available data was analyzed.
Duration of remission included CRc, CR, CRh, CR/CRh, and response duration \[CRc + PR\]. Duration of CRc, CR, CRh: the time from the date of first CRc until the date of first documented relapse for participants who achieved CRc, CR, and CRh, respectively. CR/CRh: fulfilled criteria for CR or CRh at the visit. CRh: marrow blasts \<5%, ANC ≥0.5×10\^9/L, platelets ≥50×10\^9/L, not meeting CR criteria. PR: If marrow myeloblasts between \<5% and 25% and ≤2% or missing peripheral blood blast and a decrease from baseline of at least 50% in the marrow myeloblasts and no evidence of extramedullary leukemia, the response was classified as PR. If marrow myeloblasts \<5% and ≤2% or missing peripheral blood blast and no evidence of extramedullary leukemia, the response was classified as PR even with Auer rods.
Outcome measures
| Measure |
Randomized Cohort: Gilteritinib + AZA
n=61 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
n=21 Participants
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
n=16 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
Randomized Cohort: Gilteritinib
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
Duration of Remission
Duration of CR/CRh
|
19.94 months
Interval 6.93 to
Median and upper limit of confidence interval was not estimable due to an insufficient number of events to determine 50% survival.
|
8.08 months
Interval 0.95 to 8.57
|
2.83 months
Interval 1.87 to 5.95
|
—
|
|
Duration of Remission
Duration of CR
|
25.10 months
Interval 7.39 to
Upper limit of confidence interval was not estimable due to an insufficient number of events to determine 50% survival.
|
8.25 months
Interval 0.95 to
Upper limit of confidence interval was not estimable due to an insufficient number of events to determine 50% survival.
|
NA months
Median, lower and upper limit of confidence interval was not estimable due to an insufficient number of events to determine 50% survival.
|
—
|
|
Duration of Remission
Duration of CRc
|
12.52 months
Interval 6.77 to
Upper limit of confidence interval was not estimable due to an insufficient number of events to determine 50% survival.
|
8.25 months
Interval 2.1 to 14.09
|
3.65 months
Interval 0.89 to 7.39
|
—
|
|
Duration of Remission
Duration of CRh
|
6.77 months
Interval 1.35 to 6.93
|
8.08 months
Lower and upper limit of 95% confidence interval was not estimable due to insufficient number of participants.
|
2.83 months
Interval 1.87 to 5.95
|
—
|
|
Duration of Remission
Duration of response
|
7.92 months
Interval 3.98 to 18.4
|
7.62 months
Interval 0.95 to 9.23
|
3.65 months
Interval 0.95 to 6.87
|
—
|
SECONDARY outcome
Timeframe: From baseline to 31 monthsPopulation: FAS population with available data was analyzed.
The BFI was a tool to assess fatigue severity and impact on daily function in cancer participants over 24 hours. It included 9 items. A global fatigue score was computed by averaging the scores of the 9 items measured on the numeric rating scale. Scores were calculated if ≥5 of 9 items were answered. A higher score indicates a higher degree of fatigue. The first 3 rate fatigue from 0 (no fatigue) to 10 (worst imaginable), with higher scores indicating worse outcomes. The remaining 6 assess how fatigue interferes with daily activities from 0 (no interference) to 10 (completely interferes). A global fatigue score (0-10) was the average of all items, with higher scores indicating worse fatigue. Overall BFI score is reported.
Outcome measures
| Measure |
Randomized Cohort: Gilteritinib + AZA
n=22 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
n=29 Participants
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
n=9 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
Randomized Cohort: Gilteritinib
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
Change From Baseline in Brief Fatigue Inventory (BFI)
|
0.77 Scores on scale
Standard Deviation 3.98
|
0.87 Scores on scale
Standard Deviation 2.92
|
1.37 Scores on scale
Standard Deviation 3.49
|
—
|
SECONDARY outcome
Timeframe: From first dose up to end of study duration (101 months)Population: The Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE was defined as an adverse event observed after starting administration of the study drug until 30 days from the last study treatment
Outcome measures
| Measure |
Randomized Cohort: Gilteritinib + AZA
n=15 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
n=88 Participants
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
n=54 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
Randomized Cohort: Gilteritinib
n=22 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
15 participants
|
88 participants
|
52 participants
|
22 participants
|
SECONDARY outcome
Timeframe: From baseline to end of treatment (up to 57 months)Population: SAF population with available data was analyzed.
ECOG performance scores at each assessment time were be provided by treatment group. Negative change scores indicated an improvement and positive scores indicate a decline in performance. The grades were defined as follows: 0: Fully active, able to carry on all pre-disease performance without restriction. 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. Dead.
Outcome measures
| Measure |
Randomized Cohort: Gilteritinib + AZA
n=15 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
n=88 Participants
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
n=54 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
Randomized Cohort: Gilteritinib
n=22 Participants
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Scores
Baseline: Grade 4
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Scores
Baseline: Grade 5
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Scores
Baseline: Grade 0
|
1 participants
|
15 participants
|
9 participants
|
3 participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Scores
Baseline: Grade 1
|
4 participants
|
34 participants
|
26 participants
|
6 participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Scores
Baseline: Grade 2
|
4 participants
|
28 participants
|
14 participants
|
9 participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Scores
Baseline: Grade 3
|
6 participants
|
10 participants
|
5 participants
|
3 participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Scores
End of Treatment (EOT): Grade 0
|
1 participants
|
4 participants
|
8 participants
|
2 participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Scores
EOT: Grade 1
|
1 participants
|
12 participants
|
15 participants
|
4 participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Scores
EOT: Grade 2
|
2 participants
|
12 participants
|
11 participants
|
3 participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Scores
EOT: Grade 3
|
1 participants
|
7 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Scores
EOT: Grade 4
|
1 participants
|
6 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Scores
EOT: Grade 5
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Safety Cohort: Gilteritinib + Azacitidine (AZA)
Serious events: 14 serious events
Other events: 15 other events
Deaths: 14 deaths
Randomized Cohort: Gilteritinib + AZA
Serious events: 81 serious events
Other events: 87 other events
Deaths: 70 deaths
Randomized Cohort: AZA
Serious events: 34 serious events
Other events: 46 other events
Deaths: 49 deaths
Randomized Cohort: Gilteritinib
Serious events: 20 serious events
Other events: 22 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Safety Cohort: Gilteritinib + Azacitidine (AZA)
n=15 participants at risk
Participants received 80 mg (2 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles and 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle. Depending on the safety cohort data ,the decision to initiate the randomized trial at the targeted dose was made. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib + AZA
n=88 participants at risk
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
n=54 participants at risk
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
n=22 participants at risk
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
Investigations
Staphylococcus test positive
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
3/15 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
4/88 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
53.3%
8/15 • Number of events 16 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
31.8%
28/88 • Number of events 49 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
18.5%
10/54 • Number of events 12 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
18.2%
4/22 • Number of events 10 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.3%
2/15 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.3%
2/15 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Cardiac disorders
Atrial fibrillation
|
20.0%
3/15 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
8.0%
7/88 • Number of events 9 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.7%
2/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.7%
2/54 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Congenital, familial and genetic disorders
Antithrombin III deficiency
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Congenital, familial and genetic disorders
Retinitis pigmentosa
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Eye disorders
Blindness
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Acquired macroglossia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Asthenia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
General physical health deterioration
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Generalised oedema
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Mucosal inflammation
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Multiple organ dysfunction syndrome
|
13.3%
2/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Organ failure
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Pyrexia
|
20.0%
3/15 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
12/88 • Number of events 21 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
22.7%
5/22 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Sudden death
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Hepatobiliary disorders
Hepatotoxicity
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Bacillus bacteraemia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Bacteraemia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Bacterial urethritis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Brain abscess
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Bronchitis
|
6.7%
1/15 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
COVID-19
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
4/88 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.7%
2/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Clostridium bacteraemia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.7%
5/88 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Device related infection
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Endocarditis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Fungaemia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Impetigo
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Infection
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Lower respiratory tract infection fungal
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Orchitis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Periodontitis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Peritonitis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Pneumonia
|
26.7%
4/15 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
21.6%
19/88 • Number of events 28 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
14.8%
8/54 • Number of events 9 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
22.7%
5/22 • Number of events 9 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Sepsis
|
13.3%
2/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
10.2%
9/88 • Number of events 13 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.3%
5/54 • Number of events 9 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
18.2%
4/22 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Septic embolus
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Septic shock
|
13.3%
2/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
6.8%
6/88 • Number of events 11 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
22.7%
5/22 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Systemic candida
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Platelet count decreased
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
C-reactive protein increased
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
6.7%
1/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
6.8%
6/88 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
3/22 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system leukaemia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chloroma
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Differentiation syndrome
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Nervous system disorders
Central nervous system lesion
|
6.7%
1/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Nervous system disorders
Cerebral haemorrhage
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.7%
2/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Nervous system disorders
Cluster headache
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Nervous system disorders
Intracranial haematoma
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Nervous system disorders
Seizure
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Nervous system disorders
Syncope
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Psychiatric disorders
Delirium
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Renal and urinary disorders
Acute kidney injury
|
13.3%
2/15 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
4/88 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
3/22 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
6.7%
1/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
13.3%
2/15 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Skin and subcutaneous tissue disorders
Neutrophilic dermatosis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Vascular disorders
Hypotension
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Vascular disorders
Peripheral ischaemia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Vascular disorders
Thrombosis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
Other adverse events
| Measure |
Safety Cohort: Gilteritinib + Azacitidine (AZA)
n=15 participants at risk
Participants received 80 mg (2 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles and 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle. Depending on the safety cohort data ,the decision to initiate the randomized trial at the targeted dose was made. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib + AZA
n=88 participants at risk
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: AZA
n=54 participants at risk
Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
|
Randomized Cohort: Gilteritinib
n=22 participants at risk
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
6.8%
6/88 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
4/15 • Number of events 8 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
26.1%
23/88 • Number of events 38 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
18.5%
10/54 • Number of events 10 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
31.8%
7/22 • Number of events 8 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Blood and lymphatic system disorders
Anaemia
|
53.3%
8/15 • Number of events 13 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
31.8%
28/88 • Number of events 59 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
33.3%
18/54 • Number of events 30 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
27.3%
6/22 • Number of events 10 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
3/22 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
8.0%
7/88 • Number of events 8 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.7%
2/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Blood and lymphatic system disorders
Neutropenia
|
46.7%
7/15 • Number of events 23 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
31.8%
28/88 • Number of events 104 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
29.6%
16/54 • Number of events 35 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
3/22 • Number of events 22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
40.0%
6/15 • Number of events 12 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
33.0%
29/88 • Number of events 63 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
20.4%
11/54 • Number of events 14 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
18.2%
4/22 • Number of events 11 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Cardiac disorders
Cardiac dysfunction
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Cardiac disorders
Extrasystoles
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Ear and labyrinth disorders
Vertigo
|
13.3%
2/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Eye disorders
Blepharitis
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Eye disorders
Conjunctival haemorrhage
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Eye disorders
Meibomian gland dysfunction
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Eye disorders
Ocular hyperaemia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
8.0%
7/88 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Anal incontinence
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Constipation
|
33.3%
5/15 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
39.8%
35/88 • Number of events 52 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
24.1%
13/54 • Number of events 16 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
22.7%
5/22 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Diarrhoea
|
46.7%
7/15 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
34.1%
30/88 • Number of events 53 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
18.5%
10/54 • Number of events 12 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
40.9%
9/22 • Number of events 12 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.7%
5/88 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
6.8%
6/88 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
4/88 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
8/88 • Number of events 8 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.7%
2/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.7%
5/88 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.7%
2/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Nausea
|
40.0%
6/15 • Number of events 10 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
30.7%
27/88 • Number of events 55 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
24.1%
13/54 • Number of events 13 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
3/22 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Gastrointestinal disorders
Oral pain
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Asthenia
|
13.3%
2/15 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
22.7%
20/88 • Number of events 37 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
16.7%
9/54 • Number of events 10 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Catheter site haematoma
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Catheter site haemorrhage
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Chest pain
|
13.3%
2/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Discomfort
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Fatigue
|
40.0%
6/15 • Number of events 13 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
8/88 • Number of events 10 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.3%
5/54 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Generalised oedema
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
6.8%
6/88 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Infusion site extravasation
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Injection site erythema
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Injection site reaction
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.7%
5/88 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Malaise
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Medical device pain
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Medical device site reaction
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Mucosal inflammation
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
3/22 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Oedema
|
13.3%
2/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Oedema peripheral
|
20.0%
3/15 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
29.5%
26/88 • Number of events 43 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
14.8%
8/54 • Number of events 9 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
31.8%
7/22 • Number of events 8 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
4/88 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.7%
2/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Peripheral swelling
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Physical deconditioning
|
6.7%
1/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
General disorders
Pyrexia
|
13.3%
2/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
42.0%
37/88 • Number of events 79 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
31.5%
17/54 • Number of events 18 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
22.7%
5/22 • Number of events 12 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
4/88 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Hepatobiliary disorders
Hepatocellular injury
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Acinetobacter bacteraemia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
COVID-19
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
6.8%
6/88 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
8/88 • Number of events 9 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Conjunctivitis
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.7%
5/88 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Device related infection
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
4/88 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Enterobacter bacteraemia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Enterococcal bacteraemia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.7%
5/88 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Fungal infection
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Herpes zoster
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Hordeolum
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Lip infection
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Liver abscess
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Oral candidiasis
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
10.2%
9/88 • Number of events 9 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
8.0%
7/88 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Periodontitis
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Pneumonia
|
20.0%
3/15 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
11.4%
10/88 • Number of events 15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.3%
5/54 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
3/22 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Pneumonia fungal
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Respiratory tract infection
|
13.3%
2/15 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Rhinitis
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
13.3%
2/15 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Tongue fungal infection
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
3/22 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Infections and infestations
Urinary tract infection bacterial
|
6.7%
1/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
6.8%
6/88 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
6.8%
6/88 • Number of events 8 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.3%
5/54 • Number of events 8 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
6.8%
6/88 • Number of events 8 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
6.7%
1/15 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.7%
2/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
6/15 • Number of events 8 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
17.0%
15/88 • Number of events 47 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.3%
5/54 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
3/22 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
6/15 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
21.6%
19/88 • Number of events 56 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
18.2%
4/22 • Number of events 9 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Blood alkaline phosphatase increased
|
13.3%
2/15 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
10.2%
9/88 • Number of events 14 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
6.8%
6/88 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
8/88 • Number of events 19 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Blood creatinine increased
|
26.7%
4/15 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
17.0%
15/88 • Number of events 27 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
27.3%
6/22 • Number of events 10 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Blood glucose increased
|
13.3%
2/15 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Blood magnesium decreased
|
6.7%
1/15 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Blood urea increased
|
6.7%
1/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Ejection fraction decreased
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Electrocardiogram QT prolonged
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
8/88 • Number of events 18 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.7%
5/88 • Number of events 10 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Lipase increased
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Liver function test abnormal
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Neutrophil count decreased
|
6.7%
1/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
15.9%
14/88 • Number of events 91 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
7.4%
4/54 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 8 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Oxygen saturation decreased
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Platelet count decreased
|
20.0%
3/15 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
17.0%
15/88 • Number of events 45 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
16.7%
9/54 • Number of events 22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
27.3%
6/22 • Number of events 44 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Transaminases increased
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
6.8%
6/88 • Number of events 12 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Urine output decreased
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
Weight decreased
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
10.2%
9/88 • Number of events 9 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
7.4%
4/54 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Investigations
White blood cell count decreased
|
6.7%
1/15 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
8/88 • Number of events 48 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
3/22 • Number of events 12 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.7%
4/15 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
18.2%
16/88 • Number of events 25 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
18.5%
10/54 • Number of events 12 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.7%
5/88 • Number of events 9 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Gout
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
6.8%
6/88 • Number of events 9 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
6.8%
6/88 • Number of events 8 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.7%
1/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
8.0%
7/88 • Number of events 14 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
20.0%
3/15 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
15.9%
14/88 • Number of events 25 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
18.2%
4/22 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
26.7%
4/15 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
12.5%
11/88 • Number of events 16 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.7%
2/54 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
13.3%
2/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
3/15 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
25.0%
22/88 • Number of events 48 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
18.5%
10/54 • Number of events 15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
18.2%
4/22 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
11.4%
10/88 • Number of events 32 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
17.0%
15/88 • Number of events 28 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
7.4%
4/54 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
12/88 • Number of events 37 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
3/22 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
11.4%
10/88 • Number of events 17 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.7%
2/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
3/22 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
4/88 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.7%
2/54 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
13.3%
2/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
4/88 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.3%
5/54 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
11.4%
10/88 • Number of events 12 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
3/22 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Nervous system disorders
Ataxia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
8.0%
7/88 • Number of events 12 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
7.4%
4/54 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
18.2%
4/22 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
8.0%
7/88 • Number of events 12 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Nervous system disorders
Hypoaesthesia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
4/88 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Nervous system disorders
Neuropathy peripheral
|
6.7%
1/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Nervous system disorders
Syncope
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
4/88 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Nervous system disorders
Tremor
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
10.2%
9/88 • Number of events 13 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Psychiatric disorders
Insomnia
|
13.3%
2/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
15.9%
14/88 • Number of events 16 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Renal and urinary disorders
Azotaemia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
6.8%
6/88 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.7%
2/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Renal and urinary disorders
Haematuria
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.7%
5/88 • Number of events 7 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Renal and urinary disorders
Oliguria
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Renal and urinary disorders
Renal impairment
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.7%
5/88 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
8/88 • Number of events 11 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
18.2%
4/22 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.3%
2/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
12.5%
11/88 • Number of events 17 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
7.4%
4/54 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
3/15 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
12/88 • Number of events 17 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.3%
5/54 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
3/22 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
11.4%
10/88 • Number of events 11 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
3/22 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
8.0%
7/88 • Number of events 8 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
6.8%
6/88 • Number of events 8 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.7%
2/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
3/22 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/88 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/15 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.7%
5/88 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
6.8%
6/88 • Number of events 16 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
7.4%
4/54 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
11.4%
10/88 • Number of events 13 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.3%
5/54 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.4%
3/88 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
1/22 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Vascular disorders
Deep vein thrombosis
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
2.3%
2/88 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Vascular disorders
Haematoma
|
6.7%
1/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
10.2%
9/88 • Number of events 9 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Vascular disorders
Hypertension
|
13.3%
2/15 • Number of events 3 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
10.2%
9/88 • Number of events 12 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
3.7%
2/54 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Vascular disorders
Hypotension
|
20.0%
3/15 • Number of events 4 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
13.6%
12/88 • Number of events 14 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
5.6%
3/54 • Number of events 6 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
9.1%
2/22 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Vascular disorders
Orthostatic hypotension
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
4.5%
4/88 • Number of events 5 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Vascular disorders
Phlebitis
|
6.7%
1/15 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.9%
1/54 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
|
Vascular disorders
Vasculitis
|
6.7%
1/15 • Number of events 2 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
1.1%
1/88 • Number of events 1 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/54 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
0.00%
0/22 • All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
|
Additional Information
Clinical Transparency
Astellas Pharma Global Development, Inc.
Phone: 800-888-7704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER