TriangleNCT00884312 · OUTCOME
Number of Participants With Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.
What was measured
Adverse events (AEs) were assigned a severity grade using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading scale version 3.0. Per protocol, adverse events were collected if they led to dose modification or dose discontinuation, were grade ≥ 3 or serious, or were events of peripheral neuropathy (any grade). A serious AE is one that met one or more of the following criteria: * Death * Life threatening * Required inpatient hospitalization or prolongation of an existing hospitalization * Resulted in persistent or significant disability/incapacity * A congenital anomaly/birth defect in the offspring of an exposed subject * Important medical events that, based upon appropriate medical judgment, jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes above.
Analysis population: All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010.
Groups in this outcome
Solid Tumors
Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
Multiple Myeloma
Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
| Group | Source count |
|---|---|
| Solid Tumors | 9 |
| Multiple Myeloma | 91 |
Reported measurements
Any adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Solid Tumors | 7 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 84 | Not reported | Not reported | Not reported | Not reported |
Adverse event ≥ grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Solid Tumors | 5 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 66 | Not reported | Not reported | Not reported | Not reported |
Serious adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Solid Tumors | 5 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 57 | Not reported | Not reported | Not reported | Not reported |
Fatal adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Solid Tumors | 1 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 7 | Not reported | Not reported | Not reported | Not reported |
AE leading to discontinuation of carfilzomib
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Solid Tumors | 5 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 20 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 84
- title
- Any adverse event
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 66
- title
- Adverse event ≥ grade 3
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 57
- title
- Serious adverse events
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 7
- title
- Fatal adverse events
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 20
- title
- AE leading to discontinuation of carfilzomib
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 91
- units
- Participants
- description
- Adverse events (AEs) were assigned a severity grade using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading scale version 3.0. Per protocol, adverse events were collected if they led to dose modification or dose discontinuation, were grade ≥ 3 or serious, or were events of peripheral neuropathy (any grade). A serious AE is one that met one or more of the following criteria: * Death * Life threatening * Required inpatient hospitalization or prolongation of an existing hospitalization * Resulted in persistent or significant disability/incapacity * A congenital anomaly/birth defect in the offspring of an exposed subject * Important medical events that, based upon appropriate medical judgment, jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes above.
- groups
- description
- Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
- id
- OG000
- title
- Solid Tumors
- description
- Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
- id
- OG001
- title
- Multiple Myeloma
- param Type
- NUMBER
- population Description
- All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010.
- reporting Status
- POSTED
- time Frame
- From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.
- title
- Number of Participants With Adverse Events
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice