TriangleNCT02867592 · OUTCOME
Percentage 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
- Percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 5 years (duration of protocol therapy plus 30 days after last dose of therapy)
What was measured
Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will report the percentage of patients within each disease stratum who experienced a grade 3 or higher toxicity with attribution of possible, probable, or definite while on protocol therapy or within 30 days of the last dose of therapy
Analysis population: All patients who met the evaluable for toxicity criteria outlined in section 9.5 of the ADVL1622 protocol.
Groups in this outcome
Ewing's Sarcoma
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Rhabdomyosarcoma
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Non-Rhabdomyosarcoma Soft Tissue Sarcoma
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Wilms Tumor
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Rare Tumors
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Osteosarcoma
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Ewing's Sarcoma | 13 |
| Rhabdomyosarcoma | 13 |
| Non-Rhabdomyosarcoma Soft Tissue Sarcoma | 13 |
| Wilms Tumor | 13 |
| Rare Tumors | 23 |
| Osteosarcoma | 29 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ewing's Sarcoma | 61.54 | Not reported | 31.58 | 86.14 | Not reported |
| Rhabdomyosarcoma | 38.46 | Not reported | 13.86 | 68.42 | Not reported |
| Non-Rhabdomyosarcoma Soft Tissue Sarcoma | 61.54 | Not reported | 31.58 | 86.14 | Not reported |
| Wilms Tumor | 38.46 | Not reported | 13.86 | 68.42 | Not reported |
| Rare Tumors | 60.87 | Not reported | 38.54 | 80.29 | Not reported |
| Osteosarcoma | 68.97 | Not reported | 49.17 | 84.72 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 31.58
- upper Limit
- 86.14
- value
- 61.54
- group Id
- OG001
- lower Limit
- 13.86
- upper Limit
- 68.42
- value
- 38.46
- group Id
- OG002
- lower Limit
- 31.58
- upper Limit
- 86.14
- value
- 61.54
- group Id
- OG003
- lower Limit
- 13.86
- upper Limit
- 68.42
- value
- 38.46
- group Id
- OG004
- lower Limit
- 38.54
- upper Limit
- 80.29
- value
- 60.87
- group Id
- OG005
- lower Limit
- 49.17
- upper Limit
- 84.72
- value
- 68.97
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 23
- group Id
- OG005
- value
- 29
- units
- Participants
- description
- Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will report the percentage of patients within each disease stratum who experienced a grade 3 or higher toxicity with attribution of possible, probable, or definite while on protocol therapy or within 30 days of the last dose of therapy
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Ewing's Sarcoma
- description
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Rhabdomyosarcoma
- description
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG002
- title
- Non-Rhabdomyosarcoma Soft Tissue Sarcoma
- description
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG003
- title
- Wilms Tumor
- description
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG004
- title
- Rare Tumors
- description
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG005
- title
- Osteosarcoma
- param Type
- NUMBER
- population Description
- All patients who met the evaluable for toxicity criteria outlined in section 9.5 of the ADVL1622 protocol.
- reporting Status
- POSTED
- time Frame
- Up to 5 years (duration of protocol therapy plus 30 days after last dose of therapy)
- title
- Percentage of Participants With Adverse Events
- type
- SECONDARY
- unit Of Measure
- Percentage of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice