TriangleNCT01318902 · OUTCOME
Number of Participants With Clinically Significant Abnormal Laboratory Values Reported as TEAE
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 the first dose of study drug plus 30 days after last dose of study drug or until the initiation of subsequent antineoplastic therapy (Up to approximately 13 months)
What was measured
The number of participants with any clinically significant abnormal standard safety laboratory values collected throughout the study reported as TEAEs. Parameters assessed were hematology, serum chemistry and urinalysis. Abnormal laboratory values were assessed as an AE if that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Analysis population: Safety population included all participants who received at least 1 dose of ixazomib.
Groups in this outcome
Dose Escalation Cohort: Ixazomib 4.0 mg
Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
Dose Escalation Cohort: Ixazomib 5.5 mg
Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive)
Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were not treated with any other proteasome inhibitor (PI). Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed)
Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until PD or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were previously treated with any other PI. Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
| Group | Source count |
|---|---|
| Dose Escalation Cohort: Ixazomib 4.0 mg | 6 |
| Dose Escalation Cohort: Ixazomib 5.5 mg | 5 |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive) | 5 |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed) | 11 |
Reported measurements
Thrombocytopenia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Ixazomib 4.0 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Ixazomib 5.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive) | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed) | 2 | Not reported | Not reported | Not reported | Not reported |
Anaemia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Ixazomib 4.0 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Ixazomib 5.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive) | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed) | 0 | Not reported | Not reported | Not reported | Not reported |
Neutropenia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Ixazomib 4.0 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Ixazomib 5.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed) | 1 | Not reported | Not reported | Not reported | Not reported |
Hyponatraemia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Ixazomib 4.0 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Ixazomib 5.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive) | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed) | 1 | Not reported | Not reported | Not reported | Not reported |
Hypokalaemia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Ixazomib 4.0 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Ixazomib 5.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed) | 1 | Not reported | Not reported | Not reported | Not reported |
Blood creatinine increased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Ixazomib 4.0 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Ixazomib 5.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed) | 1 | Not reported | Not reported | Not reported | Not reported |
Platelet count decreased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Ixazomib 4.0 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Ixazomib 5.5 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- title
- Thrombocytopenia
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- title
- Anaemia
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- title
- Neutropenia
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- title
- Hyponatraemia
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- title
- Hypokalaemia
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- title
- Blood creatinine increased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Platelet count decreased
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 11
- units
- Participants
- description
- The number of participants with any clinically significant abnormal standard safety laboratory values collected throughout the study reported as TEAEs. Parameters assessed were hematology, serum chemistry and urinalysis. Abnormal laboratory values were assessed as an AE if that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
- groups
- description
- Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
- id
- OG000
- title
- Dose Escalation Cohort: Ixazomib 4.0 mg
- description
- Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
- id
- OG001
- title
- Dose Escalation Cohort: Ixazomib 5.5 mg
- description
- Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were not treated with any other proteasome inhibitor (PI). Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
- id
- OG002
- title
- Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive)
- description
- Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until PD or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were previously treated with any other PI. Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
- id
- OG003
- title
- Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population included all participants who received at least 1 dose of ixazomib.
- reporting Status
- POSTED
- time Frame
- From the first dose of study drug plus 30 days after last dose of study drug or until the initiation of subsequent antineoplastic therapy (Up to approximately 13 months)
- title
- Number of Participants With Clinically Significant Abnormal Laboratory Values Reported as TEAE
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice