Trial Outcomes & Findings for Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation (NCT NCT02719574)
NCT ID: NCT02719574
Last Updated: 2025-06-26
Results Overview
A TEAE was defined as an adverse event (AE) that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of participants with TEAEs and SAEs is reported. Safety analysis set (SAS) included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
336 participants
Primary outcome timeframe
Phase 1: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
Results posted on
2025-06-26
Participant Flow
Total 336 participants enrolled in the study. In phase I, 78 participants were enrolled in single cohorts (FT-2102) and combination cohorts (FT-2102 with azacitidine/cytarabine) and in phase 2, 258 participants were enrolled in single cohorts (FT-2102) and combination cohorts (FT-2102 with azacitidine).
This study is comprised of 3 stages: A Phase 1 dose-escalation stage, a Phase 1 dose-expansion stage, and a Phase 2 stage. Participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) with IDH1-R132 mutations received olutasidenib (FT-2102) alone or with azacitidine/ cytarabine in Phase 1 and 2. Based on the totality of data from Phase 1, Recommended Phase 2 dose (RP2D) for single-agent and combination treatment was determined.
Participant milestones
| Measure |
Phase 1: FT-2102 100mg QD (Single Agent; Dose Escalation)
Participants with AML or MDS received single agent of FT-2102 100 milligram (mg) orally once daily (QD) in 28-day cycles until MTD or MED achieved.
|
Phase 1: FT-2102 150mg QD (Single Agent; Dose Escalation)
Participants with AML or MDS received single agent of FT-2102 150 mg orally QD in 28-day cycles until MTD or MED achieved.
|
Phase 1: FT-2102 150mg BID (Single Agent; Dose Escalation)
Participants with AML or MDS received single agent of FT-2102 150 mg orally BID in 28-day cycles until MTD or MED achieved.
|
Phase 1: FT-2102 300mg QD (Single Agent; Dose Escalation)
Participants with AML or MDS received single agent of FT-2102 300 mg orally QD in 28-day cycles until MTD or MED achieved.
|
Phase 1: FT-2102 150mg QD+Azacitidine (Combination Therapy; Dose Escalation)
Participants with AML or MDS received combination therapy (FT-2102 150 mg QD and azacitidine administered at the dose of 75 mg/m\^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
|
Phase 1: FT-2102 150mg BID+Azacitidine (Combination Therapy; Dose Escalation)
Participants with AML or MDS received combination therapy (FT-2102 150 mg BID and azacitidine administered at the dose of 75 mg/m\^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
|
Phase 1: FT-2102 150mg BID (Single Agent; Dose Expansion)
Participants with AML or MDS received single agent of FT-2102 150 mg orally BID in 28-day cycles until MTD or MED achieved.
|
Phase 1: FT-2102 150mg BID+Azacitidine (Combination Therapy; Dose Expansion)
Participants with AML or MDS received combination therapy (FT-2102 150 mg BID and azacitidine administered at the dose of 75 mg/m\^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
|
Phase 1: FT-2102 150mg BID+ Cytarabine (Combination Therapy; Dose Expansion)
Participants with AML harboring IDH1 mutation received FT-2102 150 mg BID in combination with low-dose cytarabine (LDAC) administered at the dose of 20 mg BID SC for 10 days every 28-day cycle until treatment discontinuation.
|
Phase 2: Cohort 1; FT-2102 (Single Agent)
Participants with relapsed/refractory (R/R) AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 2; FT-2102 (Single Agent)
Participants with AML in morphologic complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) after prior therapy with residual isocitrate dehydrogenase 1 (\[IDH1\]-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
Participants with relapsed/refractory (R/R) AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 (Dose Escalation)
STARTED
|
3
|
8
|
7
|
4
|
7
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Escalation)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Escalation)
NOT COMPLETED
|
3
|
8
|
7
|
4
|
7
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Expansion)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
31
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Expansion)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Expansion)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
31
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
153
|
18
|
5
|
20
|
21
|
20
|
10
|
11
|
|
Phase 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
153
|
18
|
5
|
20
|
21
|
20
|
10
|
11
|
Reasons for withdrawal
| Measure |
Phase 1: FT-2102 100mg QD (Single Agent; Dose Escalation)
Participants with AML or MDS received single agent of FT-2102 100 milligram (mg) orally once daily (QD) in 28-day cycles until MTD or MED achieved.
|
Phase 1: FT-2102 150mg QD (Single Agent; Dose Escalation)
Participants with AML or MDS received single agent of FT-2102 150 mg orally QD in 28-day cycles until MTD or MED achieved.
|
Phase 1: FT-2102 150mg BID (Single Agent; Dose Escalation)
Participants with AML or MDS received single agent of FT-2102 150 mg orally BID in 28-day cycles until MTD or MED achieved.
|
Phase 1: FT-2102 300mg QD (Single Agent; Dose Escalation)
Participants with AML or MDS received single agent of FT-2102 300 mg orally QD in 28-day cycles until MTD or MED achieved.
|
Phase 1: FT-2102 150mg QD+Azacitidine (Combination Therapy; Dose Escalation)
Participants with AML or MDS received combination therapy (FT-2102 150 mg QD and azacitidine administered at the dose of 75 mg/m\^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
|
Phase 1: FT-2102 150mg BID+Azacitidine (Combination Therapy; Dose Escalation)
Participants with AML or MDS received combination therapy (FT-2102 150 mg BID and azacitidine administered at the dose of 75 mg/m\^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
|
Phase 1: FT-2102 150mg BID (Single Agent; Dose Expansion)
Participants with AML or MDS received single agent of FT-2102 150 mg orally BID in 28-day cycles until MTD or MED achieved.
|
Phase 1: FT-2102 150mg BID+Azacitidine (Combination Therapy; Dose Expansion)
Participants with AML or MDS received combination therapy (FT-2102 150 mg BID and azacitidine administered at the dose of 75 mg/m\^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
|
Phase 1: FT-2102 150mg BID+ Cytarabine (Combination Therapy; Dose Expansion)
Participants with AML harboring IDH1 mutation received FT-2102 150 mg BID in combination with low-dose cytarabine (LDAC) administered at the dose of 20 mg BID SC for 10 days every 28-day cycle until treatment discontinuation.
|
Phase 2: Cohort 1; FT-2102 (Single Agent)
Participants with relapsed/refractory (R/R) AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 2; FT-2102 (Single Agent)
Participants with AML in morphologic complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) after prior therapy with residual isocitrate dehydrogenase 1 (\[IDH1\]-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
Participants with relapsed/refractory (R/R) AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 (Dose Escalation)
Other
|
0
|
2
|
1
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Escalation)
Progressive Disease
|
1
|
3
|
2
|
2
|
1
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Escalation)
HSCT Transplant
|
0
|
1
|
2
|
0
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Escalation)
Death
|
2
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Escalation)
Adverse Event
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Escalation)
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Escalation)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Expansion)
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
10
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Expansion)
HSCT Transplant
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Expansion)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Expansion)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Expansion)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Expansion)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2
Protocol Defined Disease Progression
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
65
|
8
|
2
|
4
|
9
|
11
|
3
|
4
|
|
Phase 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
27
|
0
|
1
|
1
|
1
|
2
|
2
|
3
|
|
Phase 2
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
20
|
7
|
0
|
5
|
7
|
0
|
1
|
4
|
|
Phase 2
Transplant
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
2
|
0
|
6
|
1
|
1
|
0
|
0
|
|
Phase 2
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
0
|
0
|
1
|
1
|
2
|
0
|
0
|
|
Phase 2
Investigator Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
1
|
2
|
3
|
1
|
3
|
2
|
0
|
|
Phase 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
1
|
1
|
2
|
0
|
|
Phase 2
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
Baseline characteristics by cohort
| Measure |
Phase 1: FT-2102 100mg QD (Single Agent; Dose Escalation)
n=3 Participants
Participants with AML or MDS received single agent of FT-2102 100 mg orally QD in 28-day cycles until MTD or MED achieved.
|
Phase 1: FT-2102 150mg QD (Single Agent; Dose Escalation)
n=8 Participants
Participants with AML or MDS received single agent of FT-2102 150 mg orally QD in 28-day cycles until MTD or MED achieved.
|
Phase 1: FT-2102 150mg BID (Single Agent; Dose Escalation)
n=7 Participants
Participants with AML or MDS received single agent of FT-2102 150 mg orally BID in 28-day cycles until MTD or MED achieved.
|
Phase 1: FT-2102 300mg QD (Single Agent; Dose Escalation)
n=4 Participants
Participants with AML or MDS received single agent of FT-2102 300 mg orally QD in 28-day cycles until MTD or MED achieved.
|
Phase 1: FT-2102 150mg QD+Azacitidine (Combination Therapy; Dose Escalation)
n=7 Participants
Participants with AML or MDS received combination therapy (FT-2102 150 mg QD and azacitidine administered at the dose of 75 mg/m\^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
|
Phase 1: FT-2102 150mg BID+Azacitidine (Combination Therapy; Dose Escalation)
n=8 Participants
Participants with AML or MDS received combination therapy (FT-2102 150 mg BID and azacitidine administered at the dose of 75 mg/m\^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
|
Phase 1: FT-2102 150mg BID (Single Agent; Dose Expansion)
n=9 Participants
Participants with AML or MDS received single agent of FT-2102 150 mg orally BID in 28-day cycles until MTD or MED achieved.
|
Phase 1: FT-2102 150mg BID+Azacitidine (Combination Therapy; Dose Expansion)
n=31 Participants
Participants with AML or MDS received combination therapy (FT-2102 150 mg BID and azacitidine administered at the dose of 75 mg/m\^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
|
Phase 1: FT-2102 150mg BID+ Cytarabine (Combination Therapy; Dose Expansion)
n=1 Participants
Participants with AML harboring IDH1 mutation received FT-2102 150 mg BID in combination with LDAC administered at the dose of 20 mg BID SC for 10 days every 28-day cycle until treatment discontinuation.
|
Phase 2: Cohort 1; FT-2102 (Single Agent)
n=153 Participants
Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 2; FT-2102 (Single Agent)
n=18 Participants
Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=5 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=20 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=21 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy)
n=20 Participants
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=10 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=11 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Total
n=336 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
37 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
16 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
89 Participants
n=44 Participants
|
|
Age, Customized
65 - <75 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
68 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
9 Participants
n=36 Participants
|
9 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
6 Participants
n=136 Participants
|
144 Participants
n=44 Participants
|
|
Age, Customized
>=75 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
48 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
9 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
7 Participants
n=135 Participants
|
4 Participants
n=136 Participants
|
103 Participants
n=44 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
74 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
10 Participants
n=24 Participants
|
6 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
158 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
17 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
79 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
14 Participants
n=36 Participants
|
10 Participants
n=24 Participants
|
4 Participants
n=135 Participants
|
9 Participants
n=136 Participants
|
178 Participants
n=44 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
10 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
15 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
71 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
14 Participants
n=36 Participants
|
13 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
6 Participants
n=136 Participants
|
191 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
21 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
56 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
7 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
99 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: Phase 1: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)Population: SAS analyzed. Since 150 mg BID has been established as MTD, the analysis was directed towards emphasizing findings that are most relevant for determining a safe and effective treatment strategy. Accordingly, data for the other dose levels (100 mg QD, 150 mg QD, and 300 mg QD) were combined as prespecified in statistical analysis plan (SAP).
A TEAE was defined as an adverse event (AE) that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of participants with TEAEs and SAEs is reported. Safety analysis set (SAS) included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=39 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=46 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=31 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=16 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
39 Participants
|
46 Participants
|
31 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
30 Participants
|
36 Participants
|
23 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)Population: SAS analyzed. Since 150 mg BID has been established as MTD, the analysis was directed towards emphasizing findings that are most relevant for determining a safe and effective treatment strategy. Accordingly, data for the other dose levels (100 mg QD, 150 mg QD, and 300 mg QD) were combined as prespecified in SAP.
Number of participants with change from baseline in clinically significant abnormal laboratory values for hematology, chemistry and coagulation with Grade \<1 to 4 is reported. National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 toxicity grade used to determine severity of AE. Grade 1: mild;asymptomatic/mild symptoms; Grade 2: moderate; minimal; Grade 3: severe/medically significant; Grade 4: life-threatening consequences, Grade 5: death.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=39 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=46 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=31 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=16 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Decrease(Grade 3)
|
16 Participants
|
18 Participants
|
10 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Creatinine; Increase (Grade <1)
|
2 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Creatinine; Increase (Grade 1)
|
26 Participants
|
31 Participants
|
23 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Decrease(Grade 3 or 4)
|
20 Participants
|
23 Participants
|
13 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Creatinine; Increase (Grade 3)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Creatinine; Increase (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Creatinine; Increase (Grade 3 or 4)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Increase (Grade <1)
|
35 Participants
|
39 Participants
|
28 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Increase (Grade 1)
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Creatinine; Increase (Grade 2)
|
10 Participants
|
11 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Increase (Grade 3 or 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Decrease (Grade 2)
|
9 Participants
|
10 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Decrease (Grade 3)
|
30 Participants
|
36 Participants
|
20 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Decrease (Grade <1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Decrease (Grade 1)
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Increase(Grade <1)
|
38 Participants
|
45 Participants
|
30 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Increase (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Increase (Grade 2)
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Increase (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Decrease (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Decrease(Grade 3 or 4)
|
30 Participants
|
36 Participants
|
20 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Platelets; Decrease (Grade <1)
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Platelets; Decrease (Grade 1)
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Platelets; Decrease (Grade 2)
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Platelets; Decrease (Grade 3)
|
5 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Platelets; Decrease (Grade 4)
|
31 Participants
|
37 Participants
|
20 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Platelets; Decrease (Grade 3 or 4)
|
36 Participants
|
43 Participants
|
25 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Increase (Grade <1)
|
36 Participants
|
43 Participants
|
28 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Increase (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Increase (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Increase (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Increase (Grade 3 or 4)
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Decrease (Grade <1)
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes: Decrease (Grade 1)
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Decrease (Grade 2)
|
4 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Decrease (Grade 3)
|
14 Participants
|
16 Participants
|
8 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Decrease (Grade 3 or 4)
|
33 Participants
|
39 Participants
|
19 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Neutrophils; Decrease (Grade <1)
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Neutrophils; Decrease (Grade 1)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Neutrophils; Decrease (Grade 3)
|
2 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Neutrophils; Decrease (Grade 4)
|
36 Participants
|
43 Participants
|
23 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Increase (Grade <1)
|
26 Participants
|
32 Participants
|
19 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Increase (Grade 2)
|
11 Participants
|
12 Participants
|
10 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes: Increase (Grade 3)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Increase (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Decrease(Grade <1)
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Decrease(Grade 1)
|
6 Participants
|
6 Participants
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Decrease(Grade 2)
|
10 Participants
|
14 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Decrease(Grade 4)
|
4 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Increase (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Increase (Grade 3)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Increase (Grade 4)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Increase (Grade 3 or 4)
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Decrease(Grade <1)
|
13 Participants
|
16 Participants
|
12 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Decrease(Grade 1)
|
23 Participants
|
26 Participants
|
17 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Decrease(Grade 2)
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Decrease(Grade 3)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Decrease(Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Increase(Grade <1)
|
33 Participants
|
40 Participants
|
28 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Increase(Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Increase(Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Increase(Grade 3 or 4)
|
5 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Decrease(Grade 1)
|
14 Participants
|
19 Participants
|
13 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Decrease(Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Decrease(Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Decrease(Grade 3 or 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Increase(Grade <1)
|
34 Participants
|
40 Participants
|
24 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Increase(Grade 2)
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Decrease(Grade 3)
|
4 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Decrease (Grade 1)
|
19 Participants
|
24 Participants
|
11 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Decrease (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Uric acid; Increase (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Uric acid; Increase (Grade 3 or 4)
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Albumin; Decrease(Grade <1)
|
14 Participants
|
16 Participants
|
12 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Albumin; Decrease(Grade 1)
|
12 Participants
|
12 Participants
|
10 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Albumin; Decrease(Grade 3)
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Albumin; Decrease(Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Albumin; Decrease(Grade 3 or 4)
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Increase (Grade <1)
|
33 Participants
|
40 Participants
|
26 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Increase (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Increase (Grade 3)
|
5 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Increase (Grade 3 or 4)
|
5 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Decrease(Grade <1)
|
32 Participants
|
39 Participants
|
29 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Decrease(Grade 2)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Decrease(Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Decrease(Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Decrease(Grade 3 or 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Amylase; Decrease(Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Amylase; Decrease(Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Amylase; Decrease(Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Amylase; Decrease(Grade 3 or 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Coagulation: Activated partial Thromboplastin Time; Increase(Grade <1)
|
20 Participants
|
21 Participants
|
7 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Coagulation: Activated partial Thromboplastin Time; Increase(Grade 2)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Coagulation: Activated partial Thromboplastin Time; Increase(Grade 3)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Increase (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Increase (Grade 3)
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Decrease (Grade 4)
|
19 Participants
|
23 Participants
|
11 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Neutrophils; Decrease (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Neutrophils; Decrease (Grade 3 or 4)
|
38 Participants
|
45 Participants
|
28 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Increase (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Increase (Grade 3 or 4)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Decrease(Grade 3 or 4)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Increase(Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Increase(Grade 3)
|
5 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Decrease(Grade <1)
|
24 Participants
|
26 Participants
|
17 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Decrease(Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Increase(Grade 1)
|
3 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Increase(Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Increase(Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Increase(Grade 3 or 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Decrease(Grade <1)
|
21 Participants
|
23 Participants
|
16 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Decrease(Grade 1)
|
14 Participants
|
19 Participants
|
10 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Decrease(Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Decrease(Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Decrease (Grade 3 or 4)
|
4 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Increase (Grade <1)
|
34 Participants
|
41 Participants
|
27 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Increase (Grade 1)
|
5 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Increase (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Increase (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Increase (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Increase (Grade 3 or 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Decrease (Grade <1)
|
17 Participants
|
19 Participants
|
15 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Decrease (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Decrease (Grade 3)
|
3 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Decrease (Grade 3 or 4)
|
3 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Uric acid; Increase (Grade <1)
|
25 Participants
|
31 Participants
|
21 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Uric acid; Increase (Grade 1)
|
10 Participants
|
10 Participants
|
9 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Uric acid; Increase (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Uric acid; Increase (Grade 4)
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Albumin; Decrease(Grade 2)
|
12 Participants
|
16 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Increase (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Increase (Grade 4)
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Decrease(Grade 1)
|
5 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Lipase; Increase (Grade <1)
|
18 Participants
|
18 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Lipase; Increase (Grade 1)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Lipase; Increase (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Lipase; Increase (Grade 3)
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Lipase; Increase (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Lipase; Increase (Grade 3 or 4)
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Amylase; Decrease(Grade <1)
|
19 Participants
|
19 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Amylase; Decrease(Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Coagulation: Activated partial Thromboplastin Time; Increase(Grade 1)
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Coagulation: Activated partial Thromboplastin Time; Increase(Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Coagulation: Activated partial Thromboplastin Time; Increase (Grade 3 or 4)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)Population: SAS. Here, N=Number of participants with available data. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels (100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
Number of participants with change from baseline in clinically significant abnormal ECG parameter (QTcF) is reported. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=38 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=45 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=30 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=15 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
>30 to <=60 msec
|
13 Participants
|
14 Participants
|
8 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
<=450 msec
|
23 Participants
|
26 Participants
|
16 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
>480 to <=500 msec
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
>500 msec
|
4 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
>60 msec
|
5 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
>450 to <=480 msec
|
10 Participants
|
13 Participants
|
11 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)Population: Efficacy evaluable analysis set included all participants in Phase 2, Cohort 1 with confirmed IDH1-R132 who have received the first dose of FT-2102 180 days or more prior to the analysis cutoff date. This outcome measure is applicable only for Cohort 1.
Percentage of participants with CR plus CRh (CR, Molecular CR \[CRm\], Cytogenetic CR \[CRc\], CRh) is re-ported. CR is defined as bone marrow blasts less than (\<) 5 percent (%) (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, absolute neutrophil count (ANC) greater than or equal to (\>=) 1000/μL, platelet count \>=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is defined as CR with unde-tectable IDH1m minimal residual disease (MRD) and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count \>50 × 10\^9/L and ANC \> 0.5 × 10\^9/L).
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=147 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2, Cohort 1: Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Partial Hematological Recovery (CRh) for Acute Myeloid Leukemia Assessed by Investigator Based on International Working Group (IWG) Response Criteria
|
—
|
—
|
—
|
35 Percentage of participants
Interval 27.0 to 43.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)Population: FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 3, 4, 5, 6, 7 and 8. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.
Percentage of participants with CR plus CRh (CR, Molecular CR \[CRm\]), Cytogenetic CR \[CRc\], CRh) is re-ported. CR is defined as bone marrow blasts \<5 % (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, ANC \>=1000/μL, platelet count \>=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is de-fined as CR with undetectable IDH1m MRD and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count \>50 × 10\^9/L and ANC \> 0.5 × 10\^9/L).
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=13 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=20 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=19 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=5 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=10 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=11 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2, Cohort 3, 4, 5, 6, 7, 8: Percentage of Participants With CR Plus CRh for Acute Myeloid Leukemia Assessed by Investigator Based on IWG Response Criteria
|
38 Percentage of participants
Interval 13.9 to 68.4
|
30 Percentage of participants
Interval 11.9 to 54.3
|
47 Percentage of participants
Interval 24.4 to 71.1
|
0 Percentage of participants
Interval 0.0 to 52.2
|
40 Percentage of participants
Interval 12.2 to 73.8
|
45 Percentage of participants
Interval 16.7 to 76.6
|
—
|
—
|
PRIMARY outcome
Timeframe: Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)Population: FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 4 and 5. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.
Percentage of participants with complete remission (CR) is reported. CR is defined as bone marrow blast ≤ 5% myeloblasts with normal maturation of all cell lines, peripheral blood: Hgb ≥11 grams per deciliter (g/dL), platelets ≥ 100 × 10\^9/L, neutrophils ≥ 1.0 × 10\^9/L and blasts 0%.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=8 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=1 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2, Cohort 4 and 5: Percentage of Participants With CR for MDS Assessed by IWG Response Criteria
|
—
|
—
|
13 Percentage of participants
Interval 0.3 to 52.7
|
0 Percentage of participants
Interval 0.0 to 97.5
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 4 months)Population: FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 2.
RFS is defined as the time between the date of first dose until relapse or death from any cause, whichever occurs first. RFS is calculated for all participants in Phase 2 Cohort 2. 4-Month RFS rate is defined as the percentage of participants in Phase 2 Cohort 2 who have not relapsed or died on or before their 4-month response evaluation.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=18 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2, Cohort 2: Four-month Relapse Free Survival (RFS) Rate
|
—
|
—
|
—
|
83 Percentage of participants
Interval 58.6 to 96.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)Population: The pharmacokinetic (PK) analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, number anaylzed (n) = participants with available data for specific timepoints.
Area under the plasma concentration-time curve from zero time until the last measurable concentration is presented.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=4 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=6 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=8 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=3 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=7 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=8 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Area Under the Curve (AUClast) for FT-2102
Cycle 1 Day 1
|
12100 Hour*nanograms per millilitre (h*ng/mL)
Geometric Coefficient of Variation 75.4
|
2538 Hour*nanograms per millilitre (h*ng/mL)
Geometric Coefficient of Variation 34.2
|
8955 Hour*nanograms per millilitre (h*ng/mL)
Geometric Coefficient of Variation 63.7
|
5505 Hour*nanograms per millilitre (h*ng/mL)
Geometric Coefficient of Variation 146.9
|
8529 Hour*nanograms per millilitre (h*ng/mL)
Geometric Coefficient of Variation 51.1
|
2288 Hour*nanograms per millilitre (h*ng/mL)
Geometric Coefficient of Variation 71.7
|
—
|
—
|
|
Phase 1: Area Under the Curve (AUClast) for FT-2102
Cycle 2 Day 1
|
19140 Hour*nanograms per millilitre (h*ng/mL)
Geometric Coefficient of Variation 24.0
|
26360 Hour*nanograms per millilitre (h*ng/mL)
Geometric Coefficient of Variation 22.3
|
14130 Hour*nanograms per millilitre (h*ng/mL)
Geometric Coefficient of Variation 124.0
|
13080 Hour*nanograms per millilitre (h*ng/mL)
Geometric Coefficient of Variation 63.5
|
7468 Hour*nanograms per millilitre (h*ng/mL)
Geometric Coefficient of Variation 92.6
|
20640 Hour*nanograms per millilitre (h*ng/mL)
Geometric Coefficient of Variation 71.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)Population: The PK analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, number anaylzed (n) = participants with available data for specific timepoints.
Maximum plasma concentration (Cmax) for FT-2102 is presented.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=4 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=6 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=8 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=3 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=7 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=8 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Maximum Plasma Concentration (Cmax) for FT-2102
Cycle 1 Day 1
|
708.0 Nanograms per millilitre (ng/mL)
Geometric Coefficient of Variation 58.2
|
495.5 Nanograms per millilitre (ng/mL)
Geometric Coefficient of Variation 37.4
|
535.0 Nanograms per millilitre (ng/mL)
Geometric Coefficient of Variation 58.7
|
571.5 Nanograms per millilitre (ng/mL)
Geometric Coefficient of Variation 53.1
|
543.3 Nanograms per millilitre (ng/mL)
Geometric Coefficient of Variation 39.8
|
439.9 Nanograms per millilitre (ng/mL)
Geometric Coefficient of Variation 56.2
|
—
|
—
|
|
Phase 1: Maximum Plasma Concentration (Cmax) for FT-2102
Cycle 2 Day 1
|
2907 Nanograms per millilitre (ng/mL)
Geometric Coefficient of Variation 36.1
|
3703 Nanograms per millilitre (ng/mL)
Geometric Coefficient of Variation 20.8
|
1998 Nanograms per millilitre (ng/mL)
Geometric Coefficient of Variation 112.9
|
1913 Nanograms per millilitre (ng/mL)
Geometric Coefficient of Variation 47.9
|
1101 Nanograms per millilitre (ng/mL)
Geometric Coefficient of Variation 75.4
|
3183 Nanograms per millilitre (ng/mL)
Geometric Coefficient of Variation 51.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)Population: The PK analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, number anaylzed (n) = participants with available data for specific timepoints.
Time to reach the maximum plasma concentration (Tmax) is presented.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=4 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=6 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=8 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=3 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=7 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=8 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Time to Maximum Plasma Concentration (Tmax) for FT-2102
Cycle 2 Day 1
|
1.00 hour
Interval 0.0 to 1.08
|
3.00 hour
Interval 0.0 to 7.5
|
2.00 hour
Interval 1.0 to 2.12
|
2.23 hour
Interval 2.13 to 4.0
|
2.29 hour
Interval 2.0 to 4.0
|
1.18 hour
Interval 0.0 to 2.07
|
—
|
—
|
|
Phase 1: Time to Maximum Plasma Concentration (Tmax) for FT-2102
Cycle 1 Day 1
|
23.83 hour
Interval 4.0 to 24.0
|
5.79 hour
Interval 1.0 to 7.83
|
4.00 hour
Interval 2.02 to 24.0
|
4.05 hour
Interval 2.22 to 4.12
|
4.02 hour
Interval 2.0 to 22.55
|
3.13 hour
Interval 2.03 to 4.12
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 1: Time from first dose of study drug until documentation of the first overall response (up to 82 months)Population: FAS. N=participants with PR or better as best overall response. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels (100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=18 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=22 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=10 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=5 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Time to Response (TTR) for AML
|
1.90 Months
Interval 1.0 to 5.6
|
1.90 Months
Interval 1.0 to 5.6
|
1.90 Months
Interval 1.0 to 4.7
|
1.90 Months
Interval 1.0 to 2.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 1: From date of the first response to the date of the relapse or death (up to 82 months)Population: FAS. N=participants with available data for this outcome measure. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD)were combined as prespecified in SAP.
Duration of response is defined as the time from the date of the first response to the date of the relapse or death. The estimation of median duration of overall response was done by Kaplan-Meier method.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=18 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=22 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=10 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=5 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Duration of Overall Response for AML
|
22.00 Months
Interval 3.2 to
Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
|
22.00 Months
Interval 3.2 to
Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
|
2.90 Months
Interval 0.9 to 6.4
|
3.60 Months
Interval 1.7 to
Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 1: Time from first dose of study drug until documentation of the first overall response (up to 82 months)Population: FAS. N=participants with PR or better as best overall response. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=6 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=6 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=2 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=2 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Time to Response (TTR ) for MDS
|
2.20 Months
Interval 1.0 to 8.5
|
2.20 Months
Interval 1.0 to 8.5
|
4.65 Months
Interval 1.0 to 8.3
|
4.65 Months
Interval 1.0 to 8.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 2: Time from first dose of study drug until documentation of the first overall response (up to 82 months)Population: FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. Here, Overall Number of Participants Analyzed = participants with PR or better as a best overall response. Data is reported only for Cohort 1, 3, 4, 5, 6, 7 and 8.
TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=13 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=6 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=75 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=8 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=5 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=7 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Time to Response (TTR) for Acute Myeloid Leukemia (AML)
|
1.80 Months
Interval 0.9 to 3.8
|
2.50 Months
Interval 1.0 to 4.2
|
—
|
1.90 Months
Interval 0.9 to 10.2
|
2.50 Months
Interval 1.0 to 7.6
|
1.90 Months
Interval 1.8 to 3.9
|
2.80 Months
Interval 1.1 to 5.6
|
—
|
SECONDARY outcome
Timeframe: Phase 2: From the date of the first response to the date of the relapse or death (up to 82 months)Population: FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. Data is reported only for Cohort 1, 4, 5, 6, 7 and 8. No participants achieved an overall response in Phase 2 Cohort 3. Duration of Response is not calculated for Phase 2 Cohort 2. Here, Overall Number of Participants Analyzed = participants with overall response for this outcome measure.
Duration of overall response is defined as the time from the date of the first response to the date of the relapse or death. The estimation of median duration of overall response was done by Kaplan-Meier method.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=6 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=8 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=13 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=75 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=5 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=7 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Duration of Overall Response for Acute Myeloid Leukemia (AML)
|
7.25 Months
Interval 4.9 to
Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
|
4.65 Months
Interval 2.8 to
Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
|
20.00 Months
Interval 1.9 to 28.8
|
14.80 Months
Interval 7.4 to 19.4
|
10.60 Months
Interval 3.5 to 39.6
|
20.90 Months
Interval 5.6 to
Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 2: Time from first dose of study drug until documentation of the first overall response (up to 82 months)Population: FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 4 and 5. Here, Overall Number of Participants Analyzed = participants with PR or better as a best overall response.
TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=4 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=1 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2, Cohort 4 and Cohort 5: Time to Response (TTR) for Myelodysplastic Syndrome (MDS)
|
—
|
—
|
1.50 Months
Interval 1.0 to 13.0
|
3.30 Months
Interval 3.3 to 3.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 2: From the documentation of the first response of PR or better until the date of relapse, death, whichever is earlier (up to 82 months)Population: FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable only for cohort 4 and 5. Here, Overall Number of Participants Analyzed = participants with overall response for this outcome measure.
Duration of overall response was calculated similarly to DCR but was assessed the time in months between documentation of the first response of PR or better until the date of relapse, death, whichever is earlier. The estimation of median duration of overall response was done by Kaplan-Meier method. The median duration of overall response is defined as the time at which 50% of the participants in a study have experienced the event of interest (relapse or death). Given the presence of only a single participant in the sample, there is an absence of variability in outcomes, and therefore, it was not possible to ascertain a time point at which half of the participants have experienced the event. Hence, median value could not be calculated.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=4 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=1 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2, Cohort 4 and Cohort 5: Duration of Overall Response for Myelodysplastic Syndrome (MDS)
|
—
|
—
|
11.90 Months
Interval 2.8 to
Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median for Cohort 5.
|
NA Months
Median and 95% CI could not be calculated since there is only one participant for Cohort 4.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 82 months)Population: Full analysis set (FAS) included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 2.
RFS was calculated for all participants in Phase 2 Cohort 2. RFS is defined as the time (in months) between the date of first dose until relapse or death from any cause, whichever occurs first. Relapse free survival time to event is reported for all participants in Cohort 2.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=18 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2, Cohort 2: Time to Relapse-Free Survival (RFS)
|
—
|
—
|
—
|
18.40 Months
Interval 9.5 to
Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 2: From first dose of study drug until death from any cause (up to 82 months)Population: FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102.
OS is defined as the time in months from the first dose of study drug until death from any cause. For the participants who are not known to have died by the end of study follow-up, OS will be censored on the date the participants was last known to be alive. OS is calculated using Kaplan-Meier method.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=5 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=20 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=18 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=153 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=21 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=20 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=10 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=11 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Overall Survival (OS)
|
1.20 Months
Interval 1.1 to
Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
|
25.20 Months
Interval 13.6 to
Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
|
NA Months
Interval 27.3 to
The median was not reached, since more than half of the participants in the study had not experienced the event of death at the time of analysis.
|
11.60 Months
Interval 8.9 to 15.5
|
11.60 Months
Interval 5.0 to 27.5
|
10.20 Months
Interval 4.4 to 17.9
|
14.00 Months
Interval 1.0 to 19.1
|
18.70 Months
Interval 1.6 to
Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
|
SECONDARY outcome
Timeframe: Phase 2: From first dose of study drug to disease progression, relapse, death from any cause, treatment failure, or start of other (non-protocol study drug) new antileukemia therapy (up to 82 months)Population: FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102
EFS is defined as the time in months between first dose of study drug and disease progression, relapse, death from any cause, treatment failure, or start of other (non-protocol study drug) new antileukemia therapy, whichever occurs first.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=5 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=20 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=18 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=153 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=21 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=20 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=10 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=11 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Event-free Survival (EFS)
|
1.05 Months
Interval 0.8 to
Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
|
5.70 Months
Interval 1.9 to 16.4
|
18.40 Months
Interval 9.5 to
Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
|
5.50 Months
Interval 4.3 to 7.4
|
7.80 Months
Interval 2.1 to 10.2
|
4.80 Months
Interval 2.5 to 9.7
|
5.50 Months
Interval 0.3 to
Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
|
8.10 Months
Interval 1.6 to 33.0
|
SECONDARY outcome
Timeframe: Phase 2: From baseline (8 weeks prior to first dose) up to treatment period (up to 82 months)Population: FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102.
Transfusion independence is defined as the number of participants who experience at least a 56-day period during any point on treatment without requiring a transfusion of RBC and/or platelet transfusion. Participants are classified as either "dependent" or "independent" at baseline based on their transfusion history. Those who received either platelets or pRBC or both within 8 weeks prior to the first dose of FT-2102 are considered "dependent". Number of participants with transfusion independent is reported here.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=5 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=20 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=18 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=153 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=21 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=20 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=10 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=11 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Transfusion Independence
|
0 Participants
|
12 Participants
|
15 Participants
|
72 Participants
|
13 Participants
|
14 Participants
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Phase 2: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)Population: Safety analysis set included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).
A TEAE was defined as an AE that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A SAE is defined as any untoward medical occur-rence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of participants with TEAEs and SAEs is reported.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=5 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=20 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=18 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=153 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=21 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=20 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=10 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=11 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
5 Participants
|
19 Participants
|
18 Participants
|
153 Participants
|
21 Participants
|
19 Participants
|
10 Participants
|
11 Participants
|
|
Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
4 Participants
|
12 Participants
|
6 Participants
|
115 Participants
|
18 Participants
|
13 Participants
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Phase 2: From Baseline up to 28 days after last dose of study drug (up to 82 months)Population: Safety analysis set included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).
Number of participants with change from baseline in clinically significant abnormal laboratory values for hematology, chemistry and coagulation with Grade \<1 to 4 is reported. National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 toxicity grade used to determine severity of AE. Grade 1: mild;asymptomatic/mild symptoms; Grade 2: moderate; minimal; Grade 3: severe/medically significant; Grade 4: life-threatening consequences, Grade 5: death.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=5 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=20 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=18 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=153 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=21 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=20 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=10 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=11 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Neutrophils; Decrease (Grade 2)
|
0 Participants
|
0 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Neutrophils; Decrease (Grade 3)
|
0 Participants
|
1 Participants
|
4 Participants
|
21 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Increase (Grade <1)
|
5 Participants
|
19 Participants
|
18 Participants
|
146 Participants
|
20 Participants
|
20 Participants
|
10 Participants
|
10 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Increase (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Increase (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Increase (Grade 3 or 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Decrease (Grade <1)
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Decrease (Grade 1)
|
0 Participants
|
1 Participants
|
8 Participants
|
17 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Platelets; Decrease (Grade 2)
|
0 Participants
|
2 Participants
|
3 Participants
|
14 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Decrease (Grade 2)
|
1 Participants
|
7 Participants
|
3 Participants
|
46 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Platelets; Decrease (Grade 3)
|
1 Participants
|
3 Participants
|
3 Participants
|
25 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Decrease (Grade 3)
|
4 Participants
|
11 Participants
|
4 Participants
|
86 Participants
|
18 Participants
|
12 Participants
|
7 Participants
|
9 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Decrease (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Decrease (Grade 3 or 4)
|
4 Participants
|
11 Participants
|
4 Participants
|
86 Participants
|
18 Participants
|
12 Participants
|
7 Participants
|
9 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Platelets; Decrease (Grade <1)
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Platelets; Decrease (Grade 1)
|
0 Participants
|
1 Participants
|
8 Participants
|
19 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Platelets; Decrease (Grade 4)
|
4 Participants
|
13 Participants
|
1 Participants
|
91 Participants
|
18 Participants
|
11 Participants
|
7 Participants
|
6 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Platelets; Decrease (Grade 3 or 4)
|
5 Participants
|
16 Participants
|
4 Participants
|
116 Participants
|
20 Participants
|
16 Participants
|
9 Participants
|
9 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Increase (Grade <1)
|
5 Participants
|
18 Participants
|
18 Participants
|
150 Participants
|
20 Participants
|
19 Participants
|
10 Participants
|
11 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Increase (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Increase (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Increase (Grade 3)
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Increase (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Increase (Grade 3 or 4)
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Decrease (Grade <1)
|
2 Participants
|
0 Participants
|
1 Participants
|
17 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Decrease (Grade 1)
|
0 Participants
|
0 Participants
|
2 Participants
|
8 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Decrease (Grade 2)
|
0 Participants
|
3 Participants
|
7 Participants
|
20 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Decrease (Grade 3)
|
1 Participants
|
4 Participants
|
6 Participants
|
50 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Decrease (Grade 4)
|
2 Participants
|
12 Participants
|
2 Participants
|
57 Participants
|
12 Participants
|
10 Participants
|
2 Participants
|
7 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Leukocytes; Decrease (Grade 3 or 4)
|
3 Participants
|
16 Participants
|
8 Participants
|
107 Participants
|
18 Participants
|
15 Participants
|
5 Participants
|
11 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Neutrophils; Decrease (Grade <1)
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Neutrophils; Decrease (Grade 1)
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Neutrophils; Decrease (Grade 4)
|
5 Participants
|
17 Participants
|
6 Participants
|
117 Participants
|
19 Participants
|
15 Participants
|
6 Participants
|
10 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Neutrophils; Decrease (Grade 3 or 4)
|
5 Participants
|
18 Participants
|
10 Participants
|
138 Participants
|
20 Participants
|
16 Participants
|
8 Participants
|
10 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Increase (Grade <1)
|
2 Participants
|
14 Participants
|
17 Participants
|
103 Participants
|
19 Participants
|
14 Participants
|
8 Participants
|
8 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Increase (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Increase (Grade 2)
|
3 Participants
|
5 Participants
|
1 Participants
|
36 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Increase (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Increase (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Increase (Grade 3 or 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Decrease (Grade <1)
|
1 Participants
|
1 Participants
|
2 Participants
|
18 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Decrease (Grade 1)
|
0 Participants
|
0 Participants
|
1 Participants
|
18 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Decrease (Grade 2)
|
0 Participants
|
7 Participants
|
7 Participants
|
36 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Decrease (Grade 3)
|
4 Participants
|
7 Participants
|
7 Participants
|
44 Participants
|
10 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Decrease (Grade 4)
|
0 Participants
|
4 Participants
|
1 Participants
|
27 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Lymphocytes; Decrease (Grade 3 or 4)
|
4 Participants
|
11 Participants
|
8 Participants
|
71 Participants
|
15 Participants
|
9 Participants
|
5 Participants
|
5 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Creatinine; Increase (Grade 1)
|
3 Participants
|
13 Participants
|
13 Participants
|
92 Participants
|
10 Participants
|
14 Participants
|
3 Participants
|
8 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Increase (Grade <1)
|
5 Participants
|
17 Participants
|
12 Participants
|
120 Participants
|
16 Participants
|
16 Participants
|
7 Participants
|
9 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Decrease (Grade 4)
|
1 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Increase (Grade 3 or 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Decrease (Grade <1)
|
3 Participants
|
13 Participants
|
15 Participants
|
77 Participants
|
13 Participants
|
12 Participants
|
5 Participants
|
5 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Decrease (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
12 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Decrease (Grade 3 or 4)
|
0 Participants
|
1 Participants
|
1 Participants
|
13 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Uric acid; Increase (Grade <1)
|
5 Participants
|
11 Participants
|
10 Participants
|
96 Participants
|
14 Participants
|
3 Participants
|
5 Participants
|
11 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Uric acid; Increase (Grade 1)
|
0 Participants
|
6 Participants
|
8 Participants
|
49 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Albumin; Decrease (Grade 3 or 4)
|
1 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Increase (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Coagulation: Activated partial Thromboplastin Time; Increase (Grade <1)
|
0 Participants
|
13 Participants
|
14 Participants
|
82 Participants
|
13 Participants
|
8 Participants
|
4 Participants
|
5 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Decrease (Grade 3 or 4)
|
1 Participants
|
1 Participants
|
0 Participants
|
9 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Increase (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Hematology: Hemoglobin; Increase (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Decrease (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Creatinine; Increase (Grade 2)
|
1 Participants
|
5 Participants
|
4 Participants
|
55 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Creatinine; Increase (Grade 3)
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Creatinine; Increase (Grade <1)
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Increase (Grade <1)
|
5 Participants
|
17 Participants
|
18 Participants
|
134 Participants
|
19 Participants
|
18 Participants
|
9 Participants
|
10 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Increase (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Increase (Grade 3)
|
0 Participants
|
2 Participants
|
0 Participants
|
16 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Increase (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Increase (Grade 3 or 4)
|
0 Participants
|
2 Participants
|
0 Participants
|
17 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Decrease (Grade <1)
|
5 Participants
|
17 Participants
|
15 Participants
|
136 Participants
|
18 Participants
|
19 Participants
|
10 Participants
|
10 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Decrease (Grade 1)
|
0 Participants
|
1 Participants
|
3 Participants
|
13 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Decrease (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Decrease (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Decrease (Grade 4)
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Glucose; Decrease (Grade 3 or 4)
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Lipase; Increase (Grade <1)
|
5 Participants
|
12 Participants
|
8 Participants
|
108 Participants
|
16 Participants
|
17 Participants
|
8 Participants
|
7 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Lipase; Increase (Grade 1)
|
0 Participants
|
3 Participants
|
4 Participants
|
13 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Creatinine; Increase (Grade 4)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Creatinine; Increase (Grade 3 or 4)
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Increase (Grade <1)
|
4 Participants
|
14 Participants
|
16 Participants
|
126 Participants
|
18 Participants
|
16 Participants
|
7 Participants
|
9 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Increase (Grade 1)
|
1 Participants
|
3 Participants
|
1 Participants
|
14 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Increase (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Increase (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Increase (Grade 3 or 4)
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Decrease (Grade <1)
|
4 Participants
|
14 Participants
|
13 Participants
|
83 Participants
|
13 Participants
|
16 Participants
|
4 Participants
|
6 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Decrease (Grade 1)
|
0 Participants
|
3 Participants
|
4 Participants
|
50 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Decrease (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Decrease (Grade 3)
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Decrease (Grade 4)
|
0 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Increase (Grade <1)
|
3 Participants
|
15 Participants
|
18 Participants
|
129 Participants
|
18 Participants
|
19 Participants
|
9 Participants
|
10 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Increase (Grade 1)
|
2 Participants
|
1 Participants
|
0 Participants
|
13 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Increase (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Increase (Grade 3)
|
0 Participants
|
2 Participants
|
0 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Lipase; Increase (Grade 2)
|
0 Participants
|
2 Participants
|
3 Participants
|
12 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Lipase; Increase (Grade 3)
|
0 Participants
|
0 Participants
|
1 Participants
|
11 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Increase (Grade 4)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Lipase; Increase (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Increase (Grade 3 or 4)
|
0 Participants
|
3 Participants
|
0 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Decrease (Grade <1)
|
2 Participants
|
11 Participants
|
14 Participants
|
103 Participants
|
17 Participants
|
10 Participants
|
7 Participants
|
6 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Decrease (Grade 1)
|
3 Participants
|
8 Participants
|
4 Participants
|
39 Participants
|
4 Participants
|
8 Participants
|
3 Participants
|
5 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Decrease (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Decrease (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Magnesium; Decrease (Grade 3 or 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Increase (Grade 1)
|
0 Participants
|
2 Participants
|
4 Participants
|
28 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Increase (Grade 2)
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Increase (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Increase (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Increase (Grade 3 or 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Decrease (Grade <1)
|
1 Participants
|
7 Participants
|
14 Participants
|
73 Participants
|
16 Participants
|
12 Participants
|
6 Participants
|
5 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Decrease (Grade 1)
|
3 Participants
|
8 Participants
|
4 Participants
|
64 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Decrease (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Decrease (Grade 3)
|
0 Participants
|
4 Participants
|
0 Participants
|
9 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Potassium; Decrease (Grade 3 or 4)
|
1 Participants
|
4 Participants
|
0 Participants
|
15 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Increase (Grade <1)
|
4 Participants
|
18 Participants
|
17 Participants
|
139 Participants
|
19 Participants
|
20 Participants
|
9 Participants
|
8 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Increase (Grade 1)
|
0 Participants
|
1 Participants
|
0 Participants
|
13 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Increase (Grade 2)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Increase (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Increase (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Decrease (Grade 1)
|
2 Participants
|
5 Participants
|
2 Participants
|
62 Participants
|
8 Participants
|
7 Participants
|
4 Participants
|
6 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Decrease (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Sodium; Decrease (Grade 4)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Uric acid; Increase (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Uric acid; Increase (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Uric acid; Increase (Grade 4)
|
0 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Uric acid; Increase (Grade 3 or 4)
|
0 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Albumin; Decrease (Grade <1)
|
0 Participants
|
7 Participants
|
16 Participants
|
57 Participants
|
8 Participants
|
9 Participants
|
3 Participants
|
5 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Albumin; Decrease (Grade 1)
|
2 Participants
|
6 Participants
|
1 Participants
|
41 Participants
|
7 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Albumin; Decrease (Grade 2)
|
2 Participants
|
6 Participants
|
1 Participants
|
45 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Albumin; Decrease (Grade 3)
|
1 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Albumin; Decrease (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Lipase; Increase (Grade 3 or 4)
|
0 Participants
|
0 Participants
|
1 Participants
|
12 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Amylase; Decrease (Grade <1)
|
5 Participants
|
13 Participants
|
13 Participants
|
116 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
9 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Amylase; Decrease (Grade 1)
|
0 Participants
|
3 Participants
|
3 Participants
|
24 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Amylase; Decrease (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Amylase; Decrease (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Amylase; Decrease (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Amylase; Decrease (Grade 3 or 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Coagulation: Activated partial Thromboplastin Time; Increase (Grade 1)
|
1 Participants
|
0 Participants
|
0 Participants
|
15 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Coagulation: Activated partial Thromboplastin Time; Increase (Grade 2)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Coagulation: Activated partial Thromboplastin Time; Increase (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Coagulation: Activated partial Thromboplastin Time; Increase (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Coagulation: Activated partial Thromboplastin Time; Increase (Grade 3 or 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Chemistry: Calcium; Increase (Grade 4)
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Phase 2: From Baseline up to 28 days after last dose of study drug (up to 82 months)Population: Safety analysis set included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine). Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.
Number of participants with change from baseline in clinically significant abnormal ECG parameter (QTcF) is reported. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=5 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=18 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=17 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=151 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=21 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=20 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=10 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=11 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
>30 to <=60 msec
|
2 Participants
|
3 Participants
|
3 Participants
|
43 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
>60 msec
|
0 Participants
|
3 Participants
|
0 Participants
|
10 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
<=450 msec
|
1 Participants
|
9 Participants
|
11 Participants
|
90 Participants
|
9 Participants
|
11 Participants
|
9 Participants
|
4 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
>450 to <=480 msec
|
3 Participants
|
6 Participants
|
3 Participants
|
44 Participants
|
7 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
>480 to <=500 msec
|
1 Participants
|
1 Participants
|
1 Participants
|
12 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
>500 msec
|
0 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Phase 2: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)Population: The PK analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, Overall Number of Participants Analyzed (N) and number analyzed (n) = participants with available data for specific timepoints.
Area under the plasma concentration-time curve from zero time until the last measurable concentration is presented.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=2 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=12 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=14 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=117 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=16 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=4 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=2 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=1 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Area Under the Curve (AUClast) for FT-2102
Cycle 1 Day 1
|
1880 h*ng/mL
Geometric Coefficient of Variation 77.4
|
3051 h*ng/mL
Geometric Coefficient of Variation 109.7
|
2657 h*ng/mL
Geometric Coefficient of Variation 36.8
|
2836 h*ng/mL
Geometric Coefficient of Variation 59.5
|
2031 h*ng/mL
Geometric Coefficient of Variation 69.4
|
1701 h*ng/mL
Geometric Coefficient of Variation 39.4
|
4165 h*ng/mL
Geometric Coefficient of Variation 116.5
|
3898 h*ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated due to small number of participants.
|
|
Phase 2: Area Under the Curve (AUClast) for FT-2102
Cycle 2 Day 1
|
—
|
19820 h*ng/mL
Geometric Coefficient of Variation 77.6
|
27710 h*ng/mL
Geometric Coefficient of Variation 14.9
|
20610 h*ng/mL
Geometric Coefficient of Variation 69.7
|
19610 h*ng/mL
Geometric Coefficient of Variation 62.1
|
21810 h*ng/mL
Geometric Coefficient of Variation 45.6
|
25880 h*ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated due to small number of participants.
|
19940 h*ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated due to small number of participants.
|
SECONDARY outcome
Timeframe: Phase 2: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)Population: The PK analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, Overall Number of Participants Analyzed (N) and number analyzed (n) = participants with available data for specific timepoints.
Maximum Plasma Concentartion (Cmax) for FT-2102 is presented.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=2 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=13 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=14 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=120 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=16 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=4 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=2 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=1 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Maximum Plasma Concentration (Cmax) for FT-2102
Cycle 1 Day 1
|
388.8 ng/mL
Geometric Coefficient of Variation 49.1
|
623.2 ng/mL
Geometric Coefficient of Variation 75.8
|
492.4 ng/mL
Geometric Coefficient of Variation 29.3
|
534.5 ng/mL
Geometric Coefficient of Variation 57.5
|
404.1 ng/mL
Geometric Coefficient of Variation 58.5
|
411.2 ng/mL
Geometric Coefficient of Variation 9.0
|
747.5 ng/mL
Geometric Coefficient of Variation 107.6
|
671 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated due to small number of participants.
|
|
Phase 2: Maximum Plasma Concentration (Cmax) for FT-2102
Cycle 2 Day 1
|
—
|
3239 ng/mL
Geometric Coefficient of Variation 68.7
|
3800 ng/mL
Geometric Coefficient of Variation 14.7
|
3136 ng/mL
Geometric Coefficient of Variation 62.0
|
2934 ng/mL
Geometric Coefficient of Variation 53.6
|
3043 ng/mL
Geometric Coefficient of Variation 39.3
|
3500 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated due to small number of participants.
|
3080 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated due to small number of participants.
|
SECONDARY outcome
Timeframe: Phase 2: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)Population: The PK analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, Overall Number of Participants Analyzed (N) and number analyzed (n) = participants with available data for specific timepoints.
Time to reach the maximum plasma concentration (Tmax) for FT-2102 is presented.
Outcome measures
| Measure |
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=2 Participants
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=13 Participants
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=14 Participants
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 1: FT-2102 (Single Agent)
n=120 Participants
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=16 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=4 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=2 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=1 Participants
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Time to Maximum Plasma Concentration (Tmax) for FT-2102
Cycle 1 Day 1
|
5.00 hour
Interval 2.0 to 8.0
|
4.00 hour
Interval 2.0 to 8.0
|
4.00 hour
Interval 2.0 to 8.0
|
4.00 hour
Interval 1.0 to 8.0
|
4.00 hour
Interval 2.0 to 8.0
|
4.00 hour
Interval 2.0 to 8.0
|
3.00 hour
Interval 2.0 to 4.0
|
1.00 hour
Interval 1.0 to 1.0
|
|
Phase 2: Time to Maximum Plasma Concentration (Tmax) for FT-2102
Cycle 2 Day 1
|
—
|
1.00 hour
Interval 0.0 to 8.0
|
1.00 hour
Interval 0.0 to 2.0
|
2.00 hour
Interval 0.0 to 8.0
|
1.00 hour
Interval 0.0 to 4.0
|
4.00 hour
Interval 0.0 to 8.0
|
0.00 hour
Interval 0.0 to 0.0
|
1.00 hour
Interval 1.0 to 1.0
|
Adverse Events
Phase 1: FT-2102 (Single Agent)
Serious events: 10 serious events
Other events: 15 other events
Deaths: 4 deaths
Phase 1: Total FT-2102 (Single Agent)
Serious events: 23 serious events
Other events: 29 other events
Deaths: 11 deaths
Phase 1: FT-2102 + Azacitidine (Combination Therapy)
Serious events: 30 serious events
Other events: 39 other events
Deaths: 9 deaths
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)
Serious events: 36 serious events
Other events: 46 other events
Deaths: 10 deaths
Phase 1: Overall
Serious events: 60 serious events
Other events: 76 other events
Deaths: 21 deaths
Phase 2: Cohort 1; FT-2102 (Single Agent)
Serious events: 115 serious events
Other events: 152 other events
Deaths: 50 deaths
Phase 2: Cohort 2; FT-2102 (Single Agent)
Serious events: 6 serious events
Other events: 18 other events
Deaths: 0 deaths
Phase 2: Cohort 3; FT-2102 (Single Agent)
Serious events: 4 serious events
Other events: 5 other events
Deaths: 2 deaths
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
Serious events: 12 serious events
Other events: 18 other events
Deaths: 3 deaths
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
Serious events: 18 serious events
Other events: 20 other events
Deaths: 6 deaths
Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy)
Serious events: 13 serious events
Other events: 19 other events
Deaths: 7 deaths
Phase 2: Cohort 7; FT-2102 (Single Agent)
Serious events: 8 serious events
Other events: 10 other events
Deaths: 4 deaths
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Serious events: 9 serious events
Other events: 11 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase 1: FT-2102 (Single Agent)
n=16 participants at risk
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
|
Phase 1: Total FT-2102 (Single Agent)
n=31 participants at risk
Participants with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.
|
Phase 1: FT-2102 + Azacitidine (Combination Therapy)
n=39 participants at risk
Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m\^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
|
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)
n=46 participants at risk
Participants with AML or MDS received combination therapy (FT-2102 150 mg and ≤ 300 mg and azacitidine administered at the dose of 75 mg/m\^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
|
Phase 1: Overall
n=78 participants at risk
Participants with AML or MDS received single agent (FT-2102), combination therapy (FT-2102 + azacitidine, FT-2102+ LDAC) starting at 150 mg BID dose level until MTD or MED achieved or treatment discontinuation.
|
Phase 2: Cohort 1; FT-2102 (Single Agent)
n=153 participants at risk
Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 2; FT-2102 (Single Agent)
n=18 participants at risk
Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=5 participants at risk
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=20 participants at risk
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=21 participants at risk
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy)
n=20 participants at risk
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=10 participants at risk
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=11 participants at risk
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Acute promyelocytic leukaemia differentiation syndrome
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
6/78 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.2%
14/153 • Number of events 16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Bacteraemia
|
6.2%
1/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Bacterial prostatitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Psychiatric disorders
Catatonia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Hepatobiliary disorders
Cholelithiasis
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Clostridial sepsis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Death
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Device related infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Disease progression
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
8/78 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
16.3%
25/153 • Number of events 25 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.0%
3/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
19.0%
4/21 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.0%
3/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
27.3%
3/11 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Empyema
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Encephalopathy
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Congenital, familial and genetic disorders
Familial mediterranean fever
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
18.8%
3/16 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
19.4%
6/31 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.5%
8/39 • Number of events 12 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
21.7%
10/46 • Number of events 15 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.5%
16/78 • Number of events 22 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.0%
23/153 • Number of events 28 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
40.0%
2/5 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
19.0%
4/21 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Gastrointestinal angiectasia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
General physical health deterioration
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Vascular disorders
Haematoma
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
4/153 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Human bocavirus infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Influenza
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Lipase increased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Liver abscess
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Liver function test increased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Lower respiratory tract infection fungal
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Mucormycosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Oedema peripheral
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Parotitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Platelet count decreased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Pneumonia
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
22.6%
7/31 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.2%
7/46 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
17.9%
14/78 • Number of events 18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.2%
14/153 • Number of events 14 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
19.0%
4/21 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Pulmonary mycosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Pyrexia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Red blood cell count decreased
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Seizure
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Sepsis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.9%
6/153 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
14.3%
3/21 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Septic shock
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Skin infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Social circumstances
Social stay hospitalisation
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Transaminases increased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Viral infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
White blood cell count increased
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
16.1%
5/31 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
10/78 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.9%
6/153 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
Other adverse events
| Measure |
Phase 1: FT-2102 (Single Agent)
n=16 participants at risk
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
|
Phase 1: Total FT-2102 (Single Agent)
n=31 participants at risk
Participants with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.
|
Phase 1: FT-2102 + Azacitidine (Combination Therapy)
n=39 participants at risk
Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m\^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
|
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)
n=46 participants at risk
Participants with AML or MDS received combination therapy (FT-2102 150 mg and ≤ 300 mg and azacitidine administered at the dose of 75 mg/m\^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
|
Phase 1: Overall
n=78 participants at risk
Participants with AML or MDS received single agent (FT-2102), combination therapy (FT-2102 + azacitidine, FT-2102+ LDAC) starting at 150 mg BID dose level until MTD or MED achieved or treatment discontinuation.
|
Phase 2: Cohort 1; FT-2102 (Single Agent)
n=153 participants at risk
Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 2; FT-2102 (Single Agent)
n=18 participants at risk
Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 3; FT-2102 (Single Agent)
n=5 participants at risk
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
n=20 participants at risk
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
n=21 participants at risk
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy)
n=20 participants at risk
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
|
Phase 2: Cohort 7; FT-2102 (Single Agent)
n=10 participants at risk
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
|
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
n=11 participants at risk
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
16.1%
5/31 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.5%
9/78 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
17.9%
7/39 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
19.6%
9/46 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
10/78 • Number of events 12 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.8%
15/153 • Number of events 17 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
40.0%
2/5 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.6%
7/153 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Renal and urinary disorders
Acute kidney injury
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
6/78 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.6%
7/153 • Number of events 15 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Acute promyelocytic leukaemia differentiation syndrome
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
6/78 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.2%
11/153 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
40.0%
2/5 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Alanine aminotransferase increased
|
18.8%
3/16 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.4%
6/39 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.2%
7/46 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
14.1%
11/78 • Number of events 17 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.8%
18/153 • Number of events 38 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Amylase increased
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.6%
7/153 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Angina bullosa haemorrhagica
|
6.2%
1/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
13.0%
6/46 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.5%
9/78 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.6%
7/153 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
16.1%
5/31 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.5%
8/39 • Number of events 14 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
17.4%
8/46 • Number of events 14 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
16.7%
13/78 • Number of events 23 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
10/153 • Number of events 14 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
4/16 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
16.1%
5/31 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
14.1%
11/78 • Number of events 18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.2%
14/153 • Number of events 27 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Asthenia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
25.6%
10/39 • Number of events 14 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
23.9%
11/46 • Number of events 15 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.4%
12/78 • Number of events 16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
19.6%
30/153 • Number of events 49 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
14.3%
3/21 • Number of events 13 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.0%
3/20 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
36.4%
4/11 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
6/78 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.3%
5/153 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.8%
3/16 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.9%
4/31 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.5%
9/78 • Number of events 15 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
13.7%
21/153 • Number of events 29 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
22.2%
4/18 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Blood alkaline phosphatase increased
|
12.5%
2/16 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
13.0%
6/46 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
10/78 • Number of events 16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.9%
9/153 • Number of events 19 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
40.0%
2/5 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Blood bilirubin increased
|
25.0%
4/16 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.9%
4/31 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
8/78 • Number of events 12 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.2%
8/153 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
14.3%
3/21 • Number of events 13 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Blood creatinine increased
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
13.0%
6/46 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.0%
7/78 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.2%
14/153 • Number of events 15 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
4/153 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Chest X-ray abnormal
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Chills
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.4%
6/39 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
13.0%
6/46 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.0%
7/78 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.9%
6/153 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.4%
5/78 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.9%
6/153 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
4/16 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
22.6%
7/31 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
61.5%
24/39 • Number of events 35 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
58.7%
27/46 • Number of events 41 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
43.6%
34/78 • Number of events 48 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
26.8%
41/153 • Number of events 51 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
22.2%
4/18 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
25.0%
5/20 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
33.3%
7/21 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
50.0%
10/20 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
63.6%
7/11 • Number of events 21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.9%
4/31 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.5%
9/78 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.9%
6/153 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
3/16 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
16.1%
5/31 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
38.5%
15/39 • Number of events 16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
39.1%
18/46 • Number of events 19 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
29.5%
23/78 • Number of events 24 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
16.3%
25/153 • Number of events 33 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
16.7%
3/18 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
4/20 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
19.0%
4/21 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.0%
3/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
40.0%
4/10 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
27.3%
3/11 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.8%
3/16 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
22.6%
7/31 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.5%
8/39 • Number of events 12 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
21.7%
10/46 • Number of events 14 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
21.8%
17/78 • Number of events 21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
17.0%
26/153 • Number of events 39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
4/20 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
19.0%
4/21 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
25.0%
5/20 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
30.0%
3/10 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
27.3%
3/11 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
6/78 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.9%
6/153 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Diarrhoea
|
31.2%
5/16 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
22.6%
7/31 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
41.0%
16/39 • Number of events 21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
45.7%
21/46 • Number of events 29 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
37.2%
29/78 • Number of events 38 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.3%
31/153 • Number of events 36 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
25.0%
5/20 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
33.3%
7/21 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
25.0%
5/20 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
36.4%
4/11 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Dizziness
|
18.8%
3/16 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
22.6%
7/31 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
28.2%
11/39 • Number of events 16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
23.9%
11/46 • Number of events 16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
23.1%
18/78 • Number of events 26 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
10/153 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
19.0%
4/21 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Eye disorders
Dry eye
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.4%
5/78 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
4/153 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Dysgeusia
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
13.0%
6/46 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.0%
7/78 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.6%
7/153 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
6/78 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.2%
11/153 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
4/16 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
22.6%
7/31 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
30.8%
12/39 • Number of events 22 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
28.3%
13/46 • Number of events 23 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
25.6%
20/78 • Number of events 31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.3%
31/153 • Number of events 50 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
40.0%
2/5 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.0%
3/20 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Early satiety
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
6/78 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.8%
12/153 • Number of events 18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
2/16 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
16.1%
5/31 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
17.9%
7/39 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.2%
7/46 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.4%
12/78 • Number of events 14 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
17/153 • Number of events 32 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
4/20 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
19.0%
4/21 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
27.3%
3/11 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.4%
5/78 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Eye disorders
Eye haemorrhage
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Facial pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
8/78 • Number of events 12 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.2%
14/153 • Number of events 14 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Fatigue
|
37.5%
6/16 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
41.9%
13/31 • Number of events 16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
41.0%
16/39 • Number of events 25 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
41.3%
19/46 • Number of events 28 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
41.0%
32/78 • Number of events 44 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
22.9%
35/153 • Number of events 47 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
33.3%
6/18 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
40.0%
2/5 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
30.0%
6/20 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
28.6%
6/21 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
35.0%
7/20 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
6/78 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.8%
12/153 • Number of events 13 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.2%
1/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.4%
5/78 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.2%
11/153 • Number of events 24 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.4%
5/78 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.9%
6/153 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Generalised oedema
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Gingival hypertrophy
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.3%
5/153 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
14.3%
3/21 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Gingival pain
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Vascular disorders
Haematoma
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
27.3%
3/11 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Renal and urinary disorders
Haematuria
|
18.8%
3/16 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.9%
4/31 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.5%
9/78 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.3%
5/153 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.0%
3/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.3%
5/153 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.0%
3/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
19.4%
6/31 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
33.3%
13/39 • Number of events 20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
32.6%
15/46 • Number of events 22 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
26.9%
21/78 • Number of events 29 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
13.1%
20/153 • Number of events 27 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
33.3%
6/18 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
30.0%
6/20 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
14.3%
3/21 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
30.0%
3/10 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
6/78 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.6%
7/153 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Vascular disorders
Hypertension
|
18.8%
3/16 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
16.1%
5/31 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
17.9%
7/39 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
19.6%
9/46 • Number of events 15 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
17.9%
14/78 • Number of events 20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
17/153 • Number of events 31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
4/20 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.9%
4/31 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
8/78 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.9%
6/153 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.0%
7/78 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
8/78 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
22.6%
7/31 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
33.3%
13/39 • Number of events 18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
34.8%
16/46 • Number of events 21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
29.5%
23/78 • Number of events 29 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
21.6%
33/153 • Number of events 56 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
60.0%
3/5 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
30.0%
6/20 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
4/20 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
36.4%
4/11 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
8/78 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.2%
8/153 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.0%
3/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
8/78 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.9%
6/153 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.9%
6/153 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
40.0%
2/5 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.0%
3/20 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Vascular disorders
Hypotension
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.9%
4/31 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.5%
9/78 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.6%
7/153 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
40.0%
2/5 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
4/153 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Injection site reaction
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Psychiatric disorders
Insomnia
|
25.0%
4/16 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
19.4%
6/31 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.2%
7/46 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
16.7%
13/78 • Number of events 14 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.8%
12/153 • Number of events 13 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
16.7%
3/18 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
4/20 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Lipase increased
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.4%
5/78 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
10/153 • Number of events 20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Lymphocyte count decreased
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
8/78 • Number of events 14 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Malaise
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
4/153 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.0%
3/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Psychiatric disorders
Mental status changes
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
40.0%
2/5 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
2/16 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.9%
6/153 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.3%
5/153 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
2/16 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.0%
7/78 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.9%
6/153 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
6/78 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
6/78 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.4%
5/78 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Nausea
|
37.5%
6/16 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
45.2%
14/31 • Number of events 23 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
66.7%
26/39 • Number of events 37 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
69.6%
32/46 • Number of events 43 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
60.3%
47/78 • Number of events 68 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
38.6%
59/153 • Number of events 78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
27.8%
5/18 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
60.0%
3/5 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
55.0%
11/20 • Number of events 14 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
42.9%
9/21 • Number of events 14 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
40.0%
8/20 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
72.7%
8/11 • Number of events 12 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
30.8%
12/39 • Number of events 35 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
30.4%
14/46 • Number of events 41 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
23.1%
18/78 • Number of events 47 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
13.7%
21/153 • Number of events 65 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
22.2%
4/18 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
30.0%
6/20 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
23.8%
5/21 • Number of events 16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
25.0%
5/20 • Number of events 14 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
27.3%
3/11 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Oedema peripheral
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.5%
8/39 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
21.7%
10/46 • Number of events 12 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.4%
12/78 • Number of events 14 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.0%
23/153 • Number of events 36 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.0%
3/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
19.0%
4/21 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
4/20 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
50.0%
5/10 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.2%
7/46 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.0%
7/78 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.3%
5/153 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Pain
|
6.2%
1/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
6/78 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.9%
6/153 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.9%
4/31 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.5%
8/39 • Number of events 13 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
17.4%
8/46 • Number of events 13 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.4%
12/78 • Number of events 17 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.5%
13/153 • Number of events 18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
27.3%
3/11 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.4%
5/78 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.3%
5/153 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Paronychia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Peripheral swelling
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
17.9%
7/39 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.2%
7/46 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.5%
9/78 • Number of events 12 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.6%
7/153 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Platelet count decreased
|
25.0%
4/16 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
25.8%
8/31 • Number of events 16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
46.2%
18/39 • Number of events 67 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
43.5%
20/46 • Number of events 81 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
35.9%
28/78 • Number of events 97 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.3%
31/153 • Number of events 152 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
16.7%
3/18 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
30.0%
6/20 • Number of events 34 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
42.9%
9/21 • Number of events 38 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
4/20 • Number of events 32 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
27.3%
3/11 • Number of events 20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
2/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.4%
5/78 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
6/78 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.2%
8/153 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Renal and urinary disorders
Pollakiuria
|
6.2%
1/16 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.0%
7/78 • Number of events 12 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.3%
5/153 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.8%
3/16 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.9%
4/31 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
17.9%
7/39 • Number of events 8 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
17.4%
8/46 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.4%
12/78 • Number of events 13 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.2%
8/153 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
4/153 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Pyrexia
|
25.0%
4/16 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
29.0%
9/31 • Number of events 12 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
23.1%
9/39 • Number of events 14 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
23.9%
11/46 • Number of events 16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
25.6%
20/78 • Number of events 28 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
22.9%
35/153 • Number of events 53 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
25.0%
5/20 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
30.0%
3/10 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
27.3%
3/11 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.8%
12/153 • Number of events 12 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.0%
3/20 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Red blood cell count decreased
|
25.0%
4/16 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
19.4%
6/31 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.5%
8/39 • Number of events 26 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
23.9%
11/46 • Number of events 29 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
21.8%
17/78 • Number of events 39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
26.1%
40/153 • Number of events 123 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
16.7%
3/18 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
35.0%
7/20 • Number of events 27 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
23.8%
5/21 • Number of events 22 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
25.0%
5/20 • Number of events 26 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
18.8%
3/16 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
5/39 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
8/78 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.6%
7/153 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Somnolence
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.4%
5/78 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.0%
7/78 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.8%
12/153 • Number of events 16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Tachycardia
|
18.8%
3/16 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
16.1%
5/31 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
8/78 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.3%
5/153 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.6%
7/153 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Tremor
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.9%
4/31 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.4%
5/78 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
10/153 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
18.2%
2/11 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.2%
14/153 • Number of events 20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Eye disorders
Vision blurred
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
3/16 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
25.8%
8/31 • Number of events 12 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
35.9%
14/39 • Number of events 20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
37.0%
17/46 • Number of events 23 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
32.1%
25/78 • Number of events 35 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
17.6%
27/153 • Number of events 35 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
50.0%
10/20 • Number of events 15 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
28.6%
6/21 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
30.0%
6/20 • Number of events 7 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
36.4%
4/11 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Weight decreased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.9%
5/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.4%
5/78 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.6%
7/153 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
25.0%
5/20 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
White blood cell count decreased
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.4%
6/39 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
17.4%
8/46 • Number of events 13 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
12.8%
10/78 • Number of events 15 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
4/153 • Number of events 13 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
White blood cell count increased
|
12.5%
2/16 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.7%
3/31 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.5%
8/39 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
21.7%
10/46 • Number of events 12 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
16.7%
13/78 • Number of events 16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
23.5%
36/153 • Number of events 56 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
40.0%
2/5 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
15.0%
3/20 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
14.3%
3/21 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
4/20 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Administration site pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Angina pectoris
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Vascular disorders
Aortic calcification
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Articular calcification
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Blood creatine increased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
4/153 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Blood urea increased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Bone swelling
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Reproductive system and breast disorders
Breast haemorrhage
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.9%
6/153 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Candida infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Catheter site bruise
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Catheter site rash
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.3%
5/153 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Eye disorders
Chalazion
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Coronavirus test positive
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Cystitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
4/153 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Device related infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Drug intolerance
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Ear and labyrinth disorders
Ear pain
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
4/153 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Vascular disorders
Embolism
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endotheliomatosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Enterococcus test positive
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Eosinophilic colitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Eye disorders
Eye oedema
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Psychiatric disorders
Flat affect
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Fungal rhinitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
General physical health deterioration
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Reproductive system and breast disorders
Genital erythema
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Gingival bleeding
|
12.5%
2/16 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
4/153 • Number of events 9 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
4/153 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Heart rate increased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.3%
5/153 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
4/153 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Hyperferritinaemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Influenza like illness
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Injection site erythema
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Injection site pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Liver function test increased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Lower respiratory tract infection fungal
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Lung infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Medication error
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
4/153 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.3%
5/153 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Mucosal dryness
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Nail infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum perforation
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.6%
7/153 • Number of events 10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Oral candidiasis
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Orchitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Platelet count increased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.2%
8/153 • Number of events 11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Renal and urinary disorders
Renal failure
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Seronegative arthritis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
4/78 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.5%
2/21 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Stomatitis haemorrhagic
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Temperature intolerance
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Tongue dysplasia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
2/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Tooth infection
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
11.1%
2/18 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
2/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Transaminases increased
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.3%
4/39 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
8.7%
4/46 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.4%
5/78 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
20.0%
1/5 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
4/153 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Eye disorders
Visual impairment
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
10.0%
1/10 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.0%
1/20 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.6%
1/18 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/78 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
9.1%
1/11 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.3%
5/153 • Number of events 6 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Renal and urinary disorders
Calculus urinary
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Eye disorders
Cataract
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Catheter site pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Chest discomfort
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Device related thrombosis
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Nervous system disorders
Disturbance in attention
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Investigations
Ejection fraction decreased
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Faeces discoloured
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Vascular disorders
Flushing
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Renal and urinary disorders
Hydronephrosis
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Metabolism and nutrition disorders
Increased appetite
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 4 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
7.7%
3/39 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
3/46 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
1/39 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.2%
1/46 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Gastrointestinal disorders
Oral disorder
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.8%
3/78 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.0%
3/153 • Number of events 3 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
2/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Sinus bradycardia
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.65%
1/153 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
General disorders
Systemic inflammatory response syndrome
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Renal and urinary disorders
Urinary tract pain
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/31 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
5.1%
2/39 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.3%
2/46 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.2%
1/16 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
3.2%
1/31 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
1.3%
1/78 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
4.8%
1/21 • Number of events 1 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/16 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
6.5%
2/31 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/39 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/46 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
2.6%
2/78 • Number of events 2 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/153 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/18 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/5 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/21 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/20 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/10 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
0.00%
0/11 • From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
|
Additional Information
Clinical Reporting Anchor and Disclosure (1452)
Novo Nordisk A/S
Phone: (+1) 866-867-7178
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER