Trial Outcomes & Findings for SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction (NCT NCT02348489)
NCT ID: NCT02348489
Last Updated: 2024-08-27
Results Overview
Number of participants with a best response of CR assessed based on International Working Group 2003 acute myeloid leukemia (AML) response criteria by a blinded independent pathologist.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
815 participants
Primary outcome timeframe
Up to 38 months (median follow-up of 25.5 months)
Results posted on
2024-08-27
Participant Flow
A total of 949 participants were assessed for inclusion in the study. Of these, 134 participants failed screening assessments and 815 participants were randomized.
For the efficacy analysis (all randomized participants), the total duration was 38 months, with a median follow-up of 766 days (25.5 months), lower quartile follow-up of 671 days (22.4 months), and upper quartile follow-up of 896 days (29.9 months). For safety analysis (all treated participants), total duration was 51 months. Combining participants into a single group as part of the Treatment Choice arm was pre-specified as part of the study design.
Participant milestones
| Measure |
SGI-110 (Guadecitabine)
Guadecitabine 60 mg/m\^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
|
Treatment Choice
One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) twice daily (BID) on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
|
|---|---|---|
|
Overall Study
STARTED
|
408
|
407
|
|
Overall Study
COMPLETED
|
55
|
40
|
|
Overall Study
NOT COMPLETED
|
353
|
367
|
Reasons for withdrawal
| Measure |
SGI-110 (Guadecitabine)
Guadecitabine 60 mg/m\^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
|
Treatment Choice
One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) twice daily (BID) on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
|
|---|---|---|
|
Overall Study
Death
|
336
|
335
|
|
Overall Study
Withdrawal by Subject
|
14
|
27
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
Baseline Characteristics
SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction
Baseline characteristics by cohort
| Measure |
SGI-110 (Guadecitabine)
n=408 Participants
Guadecitabine 60 mg/m\^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
|
Treatment Choice
n=407 Participants
One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
|
Total
n=815 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.9 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
75.9 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
75.9 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
177 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
342 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
231 Participants
n=5 Participants
|
242 Participants
n=7 Participants
|
473 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
365 Participants
n=5 Participants
|
345 Participants
n=7 Participants
|
710 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
71 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
311 Participants
n=5 Participants
|
291 Participants
n=7 Participants
|
602 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 38 months (median follow-up of 25.5 months)Population: The efficacy analysis set includes all randomized participants.
Number of participants with a best response of CR assessed based on International Working Group 2003 acute myeloid leukemia (AML) response criteria by a blinded independent pathologist.
Outcome measures
| Measure |
SGI-110 (Guadecitabine)
n=408 Participants
Guadecitabine 60 mg/m\^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
|
Treatment Choice
n=407 Participants
One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
|
|---|---|---|
|
Number of Participants With a Complete Response (CR)
|
79 Participants
|
71 Participants
|
PRIMARY outcome
Timeframe: At 676 death events (up to 38 months)Population: The efficacy analysis set includes all randomized participants.
Survival time was defined as the number of days from the day the participant was randomly assigned to study treatment to the date of death, regardless of cause.
Outcome measures
| Measure |
SGI-110 (Guadecitabine)
n=408 Participants
Guadecitabine 60 mg/m\^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
|
Treatment Choice
n=407 Participants
One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
|
|---|---|---|
|
Overall Survival
|
213 days
Interval 187.0 to 255.0
|
254 days
Interval 223.0 to 282.0
|
SECONDARY outcome
Timeframe: Up to 38 months (median follow-up of 25.5 months)Population: The efficacy analysis set includes all randomized participants.
CRc is reported as the number of participants with a best response of CR, complete response with incomplete platelet recovery (CRp), or complete response with incomplete blood count recovery (CRi).
Outcome measures
| Measure |
SGI-110 (Guadecitabine)
n=408 Participants
Guadecitabine 60 mg/m\^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
|
Treatment Choice
n=407 Participants
One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
|
|---|---|---|
|
Number of Participants With Composite CR (CRc)
|
93 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: Month 6Population: The efficacy analysis set includes all randomized participants.
The date of each hospital admission and discharge was collected for each participant for up to 6 months, unless the participant died or withdrew consent prior to that time. Duration of each hospital stay in days was calculated as date of discharge minus date of admission. The Number of Days Alive and Out of the Hospital (NDAOH) was calculated as: NDAOH=180 - total duration of all hospital stays within 180 days from the first treatment - number of death days before Day 180. For subjects who were lost to follow-up within 6 months, the NDAOH was calculated conservatively assuming that the subject would have died the day after the last contact day.
Outcome measures
| Measure |
SGI-110 (Guadecitabine)
n=408 Participants
Guadecitabine 60 mg/m\^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
|
Treatment Choice
n=407 Participants
One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
|
|---|---|---|
|
Number of Days Alive and Out of the Hospital
|
98.1 days
Standard Deviation 63.6
|
105.7 days
Standard Deviation 63.58
|
SECONDARY outcome
Timeframe: Up to 38 months (median follow-up of 25.5 months)Population: The efficacy analysis set includes all randomized participants.
Progression-free survival was defined as the number of days from randomization to the earliest date of investigator's assessment of disease progression, participant receiving an alternative anti-leukemia therapy (including hematopoietic cell transplant), or relapse by peripheral blood (PB) assessment or blinded bone marrow (BM) assessment, whichever occurred first, or death, regardless of cause.
Outcome measures
| Measure |
SGI-110 (Guadecitabine)
n=408 Participants
Guadecitabine 60 mg/m\^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
|
Treatment Choice
n=407 Participants
One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
159 days
Interval 136.0 to 178.0
|
166 days
Interval 148.0 to 179.0
|
SECONDARY outcome
Timeframe: Month 6Population: The efficacy analysis set includes all randomized participants.
The total number of red blood cells (RBCs) transfused or, separately, the total number of platelets transfused up to the 6-month time point for each participant was counted from the date of randomization to Day 180, the date of last contact, or date of death, whichever occurred earlier. One RBC or platelet transfusion was defined as one unit, and a single bag of RBCs or platelets was considered one unit.
Outcome measures
| Measure |
SGI-110 (Guadecitabine)
n=408 Participants
Guadecitabine 60 mg/m\^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
|
Treatment Choice
n=407 Participants
One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
|
|---|---|---|
|
Number of Red Blood Cell or Platelet Transfusions
Red Blood Cell Transfusions
|
16.2 transfusion units
Standard Deviation 11.84
|
15.6 transfusion units
Standard Deviation 13.02
|
|
Number of Red Blood Cell or Platelet Transfusions
Platelet Transfusions
|
12.5 transfusion units
Standard Deviation 18.78
|
14.4 transfusion units
Standard Deviation 39.10
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: The efficacy analysis set includes all randomized participants.
EuroQol 5-level 5-dimension (EQ-5D-5L) descriptive scores were collected for each participant for a minimum of 6 months, unless the participant died or withdrew consent. Scores within each dimension for EQ-5D (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) were calculated using counts and proportions. Mean change in scores from baseline are summarized in which an index score of 0 represents the worst health state and 1 represents the best health state.
Outcome measures
| Measure |
SGI-110 (Guadecitabine)
n=391 Participants
Guadecitabine 60 mg/m\^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
|
Treatment Choice
n=378 Participants
One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
|
|---|---|---|
|
Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-5D-5L
Baseline
|
0.7767 score on a scale
Standard Deviation 0.2160
|
0.7663 score on a scale
Standard Deviation 0.2291
|
|
Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-5D-5L
Month 6
|
0.8252 score on a scale
Standard Deviation 0.1825
|
0.8240 score on a scale
Standard Deviation 0.1948
|
|
Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-5D-5L
Change from Baseline
|
-0.0023 score on a scale
Standard Deviation 0.1830
|
0.0112 score on a scale
Standard Deviation 0.2325
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: The efficacy analysis set includes all randomized participants.
EuroQol-Visual Analogue Scale (EQ-VAS) descriptive scores were collected for each participant for a minimum of 6 months, unless the participant died or withdrew consent. A vertical 20-cm scale for EQ-VAS was used where the lowest value of 0 was labeled "the worst health you can imagine" and the top value of 100 was labeled "the best health you can imagine." Mean change in scores from baseline are summarized.
Outcome measures
| Measure |
SGI-110 (Guadecitabine)
n=391 Participants
Guadecitabine 60 mg/m\^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
|
Treatment Choice
n=377 Participants
One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
|
|---|---|---|
|
Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-VAS
Month 6
|
72.76 score on a scale
Standard Deviation 18.61
|
71.72 score on a scale
Standard Deviation 18.88
|
|
Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-VAS
Baseline
|
64.64 score on a scale
Standard Deviation 21.69
|
63.58 score on a scale
Standard Deviation 21.05
|
|
Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-VAS
Change from Baseline
|
3.28 score on a scale
Standard Deviation 19.35
|
3.67 score on a scale
Standard Deviation 22.16
|
SECONDARY outcome
Timeframe: Up to 38 months (median follow-up of 25.5 months)Population: The efficacy analysis set includes all randomized participants.
Duration of CR (in number of days) was calculated from the first time a CR was observed to the time of relapse, defined as the earliest time point whereby BM assessment or PB assessment indicated relapse/disease progression due to reappearance of leukemic blasts in PB or ≥ 5% leukemic blasts in BM.
Outcome measures
| Measure |
SGI-110 (Guadecitabine)
n=408 Participants
Guadecitabine 60 mg/m\^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
|
Treatment Choice
n=407 Participants
One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
|
|---|---|---|
|
Duration of CR
|
217 days
Interval 175.0 to 261.0
|
231 days
Interval 182.0 to 289.0
|
Adverse Events
SGI-110 (Guadecitabine)
Serious events: 327 serious events
Other events: 379 other events
Deaths: 341 deaths
Treatment Choice
Serious events: 297 serious events
Other events: 371 other events
Deaths: 344 deaths
Serious adverse events
| Measure |
SGI-110 (Guadecitabine)
n=401 participants at risk
Guadecitabine 60 mg/m\^2 was administered subcutaneously daily for 5 days (Days 1-5) in 28-day cycles.
|
Treatment Choice
n=392 participants at risk
One of the following treatment regimens were administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Hypertension
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Anemia
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.75%
3/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.0%
4/392 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.2%
101/401 • Number of events 147 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
22.4%
88/392 • Number of events 138 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Hemorrhagic diathesis
|
0.50%
2/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Histiocytosis hematophagic
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.5%
6/401 • Number of events 7 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Lymphoadenopathy
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Lymphoadenopathy mediastinal
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Monoclonal B-cell lymphocytosis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.7%
15/401 • Number of events 15 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.3%
5/392 • Number of events 5 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.75%
3/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.75%
3/401 • Number of events 6 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.77%
3/392 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Angina pectoris
|
0.75%
3/401 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.0%
4/392 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Arrhythmia
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
5/401 • Number of events 5 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.5%
6/392 • Number of events 13 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Atrial flutter
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Atrial tachycardia
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Cardiac arrest
|
0.75%
3/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
2.3%
9/392 • Number of events 9 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Cardiac failure
|
2.0%
8/401 • Number of events 8 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
2.6%
10/392 • Number of events 11 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Cardiac failure acute
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.00%
4/401 • Number of events 7 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.77%
3/392 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Cardiogenic shock
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Myocardial infarction
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.77%
3/392 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Pericarditis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Ear and labyrinth disorders
Mastoid disorder
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Endocrine disorders
Diabetes insipidus
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.00%
4/401 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Anal fissure
|
0.25%
1/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Anal fistula
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Colitis
|
0.75%
3/401 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Colitis ischemic
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Constipation
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
8/401 • Number of events 9 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.8%
7/392 • Number of events 10 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Dysphagia
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Enteritis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Fecaloma
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.50%
2/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Ileus
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Melaena
|
0.75%
3/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Esophagitis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.0%
4/392 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Small intestinal hemorrhage
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Stomatitis
|
0.75%
3/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Asthenia
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.0%
4/392 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Catheter site erythema
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Chest pain
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Death
|
1.2%
5/401 • Number of events 5 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.3%
5/392 • Number of events 5 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Device related thrombosis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Discomfort
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Fatigue
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Gait disturbance
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
General physical health deterioration
|
2.2%
9/401 • Number of events 9 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
2.6%
10/392 • Number of events 10 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Impaired healing
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Injection site reaction
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Malaise
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.2%
5/401 • Number of events 5 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.0%
4/392 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Non-cardiac chest pain
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Edema peripheral
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Pyrexia
|
4.0%
16/401 • Number of events 19 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
3.3%
13/392 • Number of events 14 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Sudden death
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Hepatobiliary disorders
Biliary colic
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Hepatobiliary disorders
Ischemic hepatitis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Immune system disorders
Anaphylactic reaction
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Abdominal wall abscess
|
0.25%
1/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Anal abscess
|
0.75%
3/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Appendicitis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Aspergillus infection
|
0.75%
3/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Bacteremia
|
1.7%
7/401 • Number of events 8 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Bacterial infection
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Bacteroides bacteremia
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Bronchitis
|
1.5%
6/401 • Number of events 6 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Cellulitis
|
0.75%
3/401 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.5%
6/392 • Number of events 7 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Cellulitis orbital
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Clostridium colitis
|
0.25%
1/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.00%
4/401 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Clostridium difficile infection
|
1.00%
4/401 • Number of events 5 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Cystitis
|
0.75%
3/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Dermo-hypodermitis
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Device related infection
|
1.00%
4/401 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.8%
7/392 • Number of events 8 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Device related sepsis
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Diverticulitis
|
1.00%
4/401 • Number of events 6 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Encephalomyelitis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Enterobacter infection
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Epiglottitis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Erysipelas
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Escherichia bacteremia
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Escherichia infection
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Eye infection
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Febrile infection
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Gastric infection
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Gastroenteritis
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Gastroenteritis pseudomonas
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Gastroenteritis viral
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Gingivitis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Hematoma infection
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Hepatosplenic abscess
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Herpes simplex
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Herpes zoster
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Herpes zoster oticus
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Infection
|
1.5%
6/401 • Number of events 6 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.3%
5/392 • Number of events 6 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Influenza
|
1.5%
6/401 • Number of events 6 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.77%
3/392 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Injection site abscess
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Injection site cellulitis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Injection site infection
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Kidney infection
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Klebsiella infection
|
0.75%
3/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Liver abscess
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Localized infection
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Mastoiditis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Mucormycosis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Muscle abscess
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Osteomyelitis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Otitis media
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Otitis media acute
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Parotitis
|
0.50%
2/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Pathogen resistance
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Periorbital cellulitis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Periumbilical abscess
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Pharyngitis
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Pneumonia
|
29.2%
117/401 • Number of events 147 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
20.2%
79/392 • Number of events 102 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Pneumonia legionella
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Pseudomonas infection
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Pyelonephritis
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Pyelonephritis acute
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Respiratory tract infection
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Scrotal infection
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Sepsis
|
15.5%
62/401 • Number of events 83 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
11.2%
44/392 • Number of events 58 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Septic shock
|
4.0%
16/401 • Number of events 17 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
4.3%
17/392 • Number of events 19 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Septic vasculitis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.0%
4/392 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Sinusitis fungal
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Skin infection
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Soft tissue infection
|
0.75%
3/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Staphylococcal bacteremia
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Hypotension
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.77%
3/392 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Staphylococcal infection
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.77%
3/392 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Streptococcal bacteremia
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Systemic candida
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Systemic infection
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Tonsillitis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Tooth infection
|
0.50%
2/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Tuberculous pleurisy
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.00%
4/401 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Urethritis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Urinary tract infection
|
3.5%
14/401 • Number of events 16 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
2.6%
10/392 • Number of events 11 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.75%
3/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Urosepsis
|
0.75%
3/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Viral infection
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Wound infection
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.25%
1/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Fall
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Hemolytic transfusion reaction
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Iliac artery embolism
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Subarachnoid hemorrhage
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Subdural hemorrhage
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
1.00%
4/401 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Traumatic lung injury
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Investigations
Blood bilirubin increased
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Investigations
C-reactive protein increased
|
0.75%
3/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.77%
3/392 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.0%
4/392 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.25%
1/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.0%
4/392 • Number of events 5 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.77%
3/392 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
1.2%
5/401 • Number of events 5 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Muscle hemorrhage
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Shoulder deformity
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary neoplasm
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system leukemia
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chloroma
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor associated fever
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Cerebral hemorrhage
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.5%
6/401 • Number of events 6 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Facial paralysis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Hemorrhage intracranial
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.0%
4/392 • Number of events 5 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Hemorrhagic stroke
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Headache
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Intracranial hematoma
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Ischemic stroke
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Nervous system disorder
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Seizure
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Syncope
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.0%
4/392 • Number of events 6 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Transient ischemic attack
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Product Issues
Device dislocation
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Psychiatric disorders
Confusional state
|
1.00%
4/401 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Psychiatric disorders
Delirium
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Psychiatric disorders
Depression
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Psychiatric disorders
Suicide attempt
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.7%
11/401 • Number of events 11 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
3.8%
15/392 • Number of events 16 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Renal and urinary disorders
Cystitis hemorrhagic
|
0.25%
1/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Renal and urinary disorders
Hematuria
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Renal and urinary disorders
Renal failure
|
1.00%
4/401 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Renal and urinary disorders
Urinary retention
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary edema
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.5%
6/392 • Number of events 6 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.50%
2/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.75%
3/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.77%
3/392 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Leriche syndrome
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Organizing pneumonia
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
6/401 • Number of events 7 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.77%
3/392 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.75%
3/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar hemorrhage
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.2%
5/401 • Number of events 5 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
5/401 • Number of events 5 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.51%
2/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.25%
1/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Aortic dissection
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Artery dissection
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Circulatory collapse
|
1.2%
5/401 • Number of events 5 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
1.0%
4/392 • Number of events 4 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Deep vein thrombosis
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Hematoma
|
0.75%
3/401 • Number of events 3 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Lupus vasculitis
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Phlebitis
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Shock
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Shock hemorrhagic
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Thrombophlebitis
|
0.50%
2/401 • Number of events 2 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.00%
0/392 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
0.00%
0/401 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.25%
1/401 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
0.26%
1/392 • Number of events 1 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
Other adverse events
| Measure |
SGI-110 (Guadecitabine)
n=401 participants at risk
Guadecitabine 60 mg/m\^2 was administered subcutaneously daily for 5 days (Days 1-5) in 28-day cycles.
|
Treatment Choice
n=392 participants at risk
One of the following treatment regimens were administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
21.9%
88/401 • Number of events 211 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
19.9%
78/392 • Number of events 201 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.5%
66/401 • Number of events 103 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
10.2%
40/392 • Number of events 57 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.2%
37/401 • Number of events 120 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
8.4%
33/392 • Number of events 124 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.7%
115/401 • Number of events 319 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
22.4%
88/392 • Number of events 233 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.9%
116/401 • Number of events 380 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
25.8%
101/392 • Number of events 313 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
30/401 • Number of events 43 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
11.7%
46/392 • Number of events 50 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.2%
21/401 • Number of events 25 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
3.8%
15/392 • Number of events 16 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Constipation
|
31.2%
125/401 • Number of events 166 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
29.1%
114/392 • Number of events 168 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Diarrhea
|
30.4%
122/401 • Number of events 169 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
21.2%
83/392 • Number of events 116 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.0%
24/401 • Number of events 28 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
4.8%
19/392 • Number of events 24 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Nausea
|
22.7%
91/401 • Number of events 141 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
27.6%
108/392 • Number of events 150 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Stomatitis
|
11.5%
46/401 • Number of events 59 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
9.7%
38/392 • Number of events 44 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Gastrointestinal disorders
Vomiting
|
14.5%
58/401 • Number of events 80 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
16.8%
66/392 • Number of events 82 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Asthenia
|
15.2%
61/401 • Number of events 102 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
14.0%
55/392 • Number of events 81 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Fatigue
|
15.7%
63/401 • Number of events 97 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
12.8%
50/392 • Number of events 74 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Injection site reaction
|
18.2%
73/401 • Number of events 148 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
12.2%
48/392 • Number of events 75 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Edema peripheral
|
23.7%
95/401 • Number of events 125 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
19.9%
78/392 • Number of events 108 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Pain
|
5.2%
21/401 • Number of events 22 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
3.6%
14/392 • Number of events 14 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
General disorders
Pyrexia
|
22.2%
89/401 • Number of events 155 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
28.1%
110/392 • Number of events 176 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Bronchitis
|
5.5%
22/401 • Number of events 30 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
3.3%
13/392 • Number of events 15 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Cellulitis
|
7.2%
29/401 • Number of events 37 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
5.6%
22/392 • Number of events 25 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
18/401 • Number of events 27 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
5.1%
20/392 • Number of events 21 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Oral candidiasis
|
5.7%
23/401 • Number of events 27 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
4.3%
17/392 • Number of events 21 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Oral herpes
|
7.7%
31/401 • Number of events 36 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
5.1%
20/392 • Number of events 21 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Pneumonia
|
13.5%
54/401 • Number of events 64 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
7.9%
31/392 • Number of events 34 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.5%
22/401 • Number of events 34 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
5.1%
20/392 • Number of events 28 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Infections and infestations
Urinary tract infection
|
8.2%
33/401 • Number of events 46 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
7.1%
28/392 • Number of events 39 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
20/401 • Number of events 23 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
5.6%
22/392 • Number of events 27 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Injury, poisoning and procedural complications
Fall
|
8.5%
34/401 • Number of events 43 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
7.4%
29/392 • Number of events 37 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Investigations
Weight decreased
|
8.7%
35/401 • Number of events 47 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
6.4%
25/392 • Number of events 28 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.2%
89/401 • Number of events 116 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
15.8%
62/392 • Number of events 80 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.0%
24/401 • Number of events 33 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
3.3%
13/392 • Number of events 19 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.5%
26/401 • Number of events 36 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
5.9%
23/392 • Number of events 43 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.2%
25/401 • Number of events 30 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
4.6%
18/392 • Number of events 29 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.9%
96/401 • Number of events 173 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
19.6%
77/392 • Number of events 128 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.7%
31/401 • Number of events 50 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
6.9%
27/392 • Number of events 36 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
24/401 • Number of events 28 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
8.9%
35/392 • Number of events 39 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.5%
34/401 • Number of events 43 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
9.2%
36/392 • Number of events 43 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.2%
17/401 • Number of events 20 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
5.1%
20/392 • Number of events 22 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
40/401 • Number of events 51 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
8.2%
32/392 • Number of events 39 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Dizziness
|
9.0%
36/401 • Number of events 47 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
10.7%
42/392 • Number of events 56 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Nervous system disorders
Headache
|
8.0%
32/401 • Number of events 44 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
9.7%
38/392 • Number of events 53 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Psychiatric disorders
Anxiety
|
5.7%
23/401 • Number of events 23 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
5.6%
22/392 • Number of events 24 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Psychiatric disorders
Depression
|
3.5%
14/401 • Number of events 15 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
5.4%
21/392 • Number of events 21 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Psychiatric disorders
Insomnia
|
9.5%
38/401 • Number of events 52 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
11.5%
45/392 • Number of events 56 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.7%
23/401 • Number of events 24 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
4.1%
16/392 • Number of events 17 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.7%
79/401 • Number of events 100 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
16.8%
66/392 • Number of events 83 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.7%
63/401 • Number of events 83 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
13.0%
51/392 • Number of events 60 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.2%
53/401 • Number of events 71 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
9.2%
36/392 • Number of events 51 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.5%
22/401 • Number of events 29 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
5.9%
23/392 • Number of events 27 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.2%
21/401 • Number of events 23 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
3.3%
13/392 • Number of events 13 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.2%
21/401 • Number of events 21 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
4.3%
17/392 • Number of events 20 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.5%
22/401 • Number of events 28 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
6.6%
26/392 • Number of events 32 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.2%
41/401 • Number of events 55 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
7.1%
28/392 • Number of events 33 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Hematoma
|
6.2%
25/401 • Number of events 33 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
4.8%
19/392 • Number of events 29 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Hypertension
|
7.0%
28/401 • Number of events 42 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
6.4%
25/392 • Number of events 37 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Vascular disorders
Hypotension
|
7.7%
31/401 • Number of events 40 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
7.9%
31/392 • Number of events 37 • Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place