TriangleNCT02166463 · OUTCOME
Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale
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
- From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.
What was measured
The percentages of patients experiencing grade 3+ peripheral neuropathy assessed by the treating clinician using the modified Balis scale. The "Modified Balis scale of Pediatric Neuropathy" allows clinicians to assign a score for sensory or motor neuropathy symptoms separately. Scores range from 1 to 4 with 1 being the least symptomatic state and 4 indicating a severe debility. The percentages of patients (with a score \>/=3) will be compared between the 2 arms by two-sample Z test at 1-sided alpha level of 0.05.
Analysis population: All the eligible patients who had undergone randomization
Groups in this outcome
Arm I (ABVE-PC)
Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
ARM II (Bv-AVEPC)
Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm I (ABVE-PC) | 289 |
| ARM II (Bv-AVEPC) | 298 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (ABVE-PC) | 5.5 | Not reported | 2.90 | 8.17 | Not reported |
| ARM II (Bv-AVEPC) | 6.7 | Not reported | 3.87 | 9.55 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.90
- upper Limit
- 8.17
- value
- 5.5
- group Id
- OG001
- lower Limit
- 3.87
- upper Limit
- 9.55
- value
- 6.7
- denoms
- counts
- group Id
- OG000
- value
- 289
- group Id
- OG001
- value
- 298
- units
- Participants
- description
- The percentages of patients experiencing grade 3+ peripheral neuropathy assessed by the treating clinician using the modified Balis scale. The "Modified Balis scale of Pediatric Neuropathy" allows clinicians to assign a score for sensory or motor neuropathy symptoms separately. Scores range from 1 to 4 with 1 being the least symptomatic state and 4 indicating a severe debility. The percentages of patients (with a score \>/=3) will be compared between the 2 arms by two-sample Z test at 1-sided alpha level of 0.05.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm I (ABVE-PC)
- description
- Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- ARM II (Bv-AVEPC)
- param Type
- NUMBER
- population Description
- All the eligible patients who had undergone randomization
- reporting Status
- POSTED
- time Frame
- From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.
- title
- Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale
- type
- SECONDARY
- unit Of Measure
- Percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice