TriangleNCT01274338 · OUTCOME
Recurrence-free Survival (RFS; Arm A [HIP] vs. Arm B [HDI])
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- years
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 years
What was measured
Recurrence-free survival is defined as the time from randomization to recurrence or death, whichever occurs first. The following criteria constitute the only acceptable evidence of disease recurrence. Lung and liver: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease. Central Nervous System: A positive brain CT or MRI scan or CSF cytology. Cutaneous, Subcutaneous and Lymph Node Recurrence: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease. Bone and Other Organs: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease identified on two different radiologic studies: i.e., positive nuclear bone scan or PET scan and contrast GI series or ultrasound, X-ray or CT of abdomen for abdominal disease.
Analysis population: Concurrently randomized patients on Arms A and B
Groups in this outcome
Arm A (HIP)
Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
Arm B (HDI)
Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm A (HIP) | 511 |
| Arm B (HDI) | 478 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (HIP) | 3.9 | Not reported | 2.9 | NA | The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment. |
| Arm B (HDI) | 2.4 | Not reported | 1.6 | 3.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
- group Id
- OG000
- lower Limit
- 2.9
- upper Limit
- NA
- value
- 3.9
- group Id
- OG001
- lower Limit
- 1.6
- upper Limit
- 3.0
- value
- 2.4
- denoms
- counts
- group Id
- OG000
- value
- 511
- group Id
- OG001
- value
- 478
- units
- Participants
- description
- Recurrence-free survival is defined as the time from randomization to recurrence or death, whichever occurs first. The following criteria constitute the only acceptable evidence of disease recurrence. Lung and liver: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease. Central Nervous System: A positive brain CT or MRI scan or CSF cytology. Cutaneous, Subcutaneous and Lymph Node Recurrence: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease. Bone and Other Organs: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease identified on two different radiologic studies: i.e., positive nuclear bone scan or PET scan and contrast GI series or ultrasound, X-ray or CT of abdomen for abdominal disease.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm A (HIP)
- description
- Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Arm B (HDI)
- param Type
- MEDIAN
- population Description
- Concurrently randomized patients on Arms A and B
- reporting Status
- POSTED
- time Frame
- Assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 years
- title
- Recurrence-free Survival (RFS; Arm A [HIP] vs. Arm B [HDI])
- type
- PRIMARY
- unit Of Measure
- years
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice