TriangleNCT02719574 · OUTCOME
Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Phase 2: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
What was measured
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.
Analysis population: Safety analysis set included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).
Groups in this outcome
Phase 2: Cohort 1; FT-2102 (Single Agent)
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)
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)
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 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.
| Group | Source count |
|---|---|
| Phase 2: Cohort 1; FT-2102 (Single Agent) | 153 |
| Phase 2: Cohort 2; FT-2102 (Single Agent) | 18 |
| Phase 2: Cohort 3; FT-2102 (Single Agent) | 5 |
| Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 20 |
| Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 21 |
| Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy) | 20 |
| Phase 2: Cohort 7; FT-2102 (Single Agent) | 10 |
| Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy) | 11 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Cohort 1; FT-2102 (Single Agent) | 153 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 2; FT-2102 (Single Agent) | 18 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 3; FT-2102 (Single Agent) | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 19 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 21 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy) | 19 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 7; FT-2102 (Single Agent) | 10 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy) | 11 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Cohort 1; FT-2102 (Single Agent) | 115 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 2; FT-2102 (Single Agent) | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 3; FT-2102 (Single Agent) | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 12 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 18 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy) | 13 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 7; FT-2102 (Single Agent) | 8 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy) | 9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 153
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 21
- group Id
- OG005
- value
- 19
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 11
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 115
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 18
- group Id
- OG005
- value
- 13
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 9
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 153
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 20
- group Id
- OG004
- value
- 21
- group Id
- OG005
- value
- 20
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 11
- units
- Participants
- description
- 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.
- groups
- description
- Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
- id
- OG000
- title
- Phase 2: Cohort 1; FT-2102 (Single Agent)
- description
- 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.
- id
- OG001
- title
- Phase 2: Cohort 2; FT-2102 (Single Agent)
- description
- 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.
- id
- OG002
- title
- Phase 2: Cohort 3; FT-2102 (Single Agent)
- description
- 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.
- id
- OG003
- title
- Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
- description
- 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.
- id
- OG004
- title
- Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
- description
- 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.
- id
- OG005
- title
- Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy)
- description
- 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.
- id
- OG006
- title
- Phase 2: Cohort 7; FT-2102 (Single Agent)
- description
- 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.
- id
- OG007
- title
- Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).
- reporting Status
- POSTED
- time Frame
- Phase 2: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
- title
- Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice