TriangleNCT02303821 · OUTCOME
Phase 1b: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
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
- From first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks
What was measured
An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are AEs that occurred after the start of study treatment and up to the end of the study or 30 days of the last study treatment, whichever is earlier. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. Treatment-related AEs (TRAEs) were TEAEs considered related to at least one study drug by the investigator, including those with unknown relationship. A serious AE (SAE) was defined as any untoward medical occurrence that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
Analysis population: Phase 1b Safety Analysis Set: All participants who received any amount of the study treatment regimen.
Groups in this outcome
Phase 1b: Dose Escalation 1 (20 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 2 (20/45 mg/m^2
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
| Group | Source count |
|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 5 |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 6 |
| Phase 1b: Dose Escalation 2 (20/27 mg/m^2) | 3 |
| Phase 1b: Dose Escalation 2 (20/36 mg/m^2) | 7 |
| Phase 1b: Dose Escalation 2 (20/45 mg/m^2 | 4 |
| Phase 1b: Dose Escalation 2 (20/56 mg/m^2) | 10 |
Reported measurements
All TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/27 mg/m^2) | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/36 mg/m^2) | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/45 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/56 mg/m^2) | 9 | Not reported | Not reported | Not reported | Not reported |
All fatal TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/27 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/36 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/45 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/56 mg/m^2) | 3 | Not reported | Not reported | Not reported | Not reported |
All TRAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/27 mg/m^2) | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/36 mg/m^2) | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/45 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/56 mg/m^2) | 8 | Not reported | Not reported | Not reported | Not reported |
All fatal TRAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/27 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/36 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/45 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/56 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
All SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/27 mg/m^2) | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/36 mg/m^2) | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/45 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/56 mg/m^2) | 7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 9
- title
- All TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 3
- title
- All fatal TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 8
- title
- All TRAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- title
- All fatal TRAEs
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 7
- title
- All SAEs
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 10
- units
- Participants
- description
- An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are AEs that occurred after the start of study treatment and up to the end of the study or 30 days of the last study treatment, whichever is earlier. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. Treatment-related AEs (TRAEs) were TEAEs considered related to at least one study drug by the investigator, including those with unknown relationship. A serious AE (SAE) was defined as any untoward medical occurrence that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
- groups
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG000
- title
- Phase 1b: Dose Escalation 1 (20 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG001
- title
- Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG002
- title
- Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG003
- title
- Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG004
- title
- Phase 1b: Dose Escalation 2 (20/45 mg/m^2
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG005
- title
- Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Phase 1b Safety Analysis Set: All participants who received any amount of the study treatment regimen.
- reporting Status
- POSTED
- time Frame
- From first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks
- title
- Phase 1b: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice