TriangleNCT00006436 · OUTCOME
Median Duration of Complete Response/Complete Response Unconfirmed
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
- The participants were followed for duration of complete response or complete response unconfirmed for a median of 15.4 years.
What was measured
Complete response (CR) was assessed by the Cheson response criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes \> 1.5 cm before therapy). Complete response unconfirmed (CRu) is when a residual lymph node mass \> 1.5 cm in greatest transverse diameter that has regressed by \> 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. In organs involved by disease, any residual lesions that have decreased by \> 75% in sum of the products of the greatest diameters or are \< 1 cm, are consistent with scar, and stable over the last two treatments will be considered to fulfill criteria for CR.
Analysis population: One participant declined to participate before treatment started.
Groups in this outcome
Arm 1-Combination Chemo and Biological Therapy
Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
| Group | Source count |
|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 67 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 13.9 | Not reported | 13.1 | NA | Upper end confidence interval is not estimable because the number of events beyond the median, and their timing, does not permit calculation of the upper confidence interval. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper end confidence interval is not estimable because the number of events beyond the median, and their timing, does not permit calculation of the upper confidence interval.
- group Id
- OG000
- lower Limit
- 13.1
- upper Limit
- NA
- value
- 13.9
- denoms
- counts
- group Id
- OG000
- value
- 67
- units
- Participants
- description
- Complete response (CR) was assessed by the Cheson response criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes \> 1.5 cm before therapy). Complete response unconfirmed (CRu) is when a residual lymph node mass \> 1.5 cm in greatest transverse diameter that has regressed by \> 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. In organs involved by disease, any residual lesions that have decreased by \> 75% in sum of the products of the greatest diameters or are \< 1 cm, are consistent with scar, and stable over the last two treatments will be considered to fulfill criteria for CR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
- id
- OG000
- title
- Arm 1-Combination Chemo and Biological Therapy
- param Type
- MEDIAN
- population Description
- One participant declined to participate before treatment started.
- reporting Status
- POSTED
- time Frame
- The participants were followed for duration of complete response or complete response unconfirmed for a median of 15.4 years.
- title
- Median Duration of Complete Response/Complete Response Unconfirmed
- type
- SECONDARY
- unit Of Measure
- years
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice