TriangleNCT01653028 · OUTCOME
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
- During treatment and up to 5 years
What was measured
Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.
Analysis population: All patients that began study treatment were assessed for this endpoint.
Groups in this outcome
Cohort 1
Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohort 2
Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohort 3
Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohort 4
Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohort 5
Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Cohort 1 | 12 |
| Cohort 2 | 10 |
| Cohort 3 | 11 |
| Cohort 4 | 10 |
| Cohort 5 | 29 |
Reported measurements
Grade 4 Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5 | 4 | Not reported | Not reported | Not reported | Not reported |
Grade 5 Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 4
- title
- Grade 4 Event
- 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
- title
- Grade 5 Event
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 29
- units
- Participants
- description
- Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.
- groups
- description
- Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Cohort 1
- description
- Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Cohort 2
- description
- Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- OG002
- title
- Cohort 3
- description
- Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- OG003
- title
- Cohort 4
- description
- Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- OG004
- title
- Cohort 5
- param Type
- NUMBER
- population Description
- All patients that began study treatment were assessed for this endpoint.
- reporting Status
- POSTED
- time Frame
- During treatment and up to 5 years
- title
- Adverse Events
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice