TriangleNCT02823574 · OUTCOME
Duration of Response (DOR) - Platinum Eligible Subgroup Based on HPV p-16 Status
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to disease progression or death. Approximately 63 Months
What was measured
The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Analysis population: All treated participants in the Platinum Eligible subgroup with a response
Groups in this outcome
Treatment A - Platinum Eligible Subgroup
Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Treatment B - Platinum Eligible Subgroup
Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
| Group | Source count |
|---|---|
| Treatment A - Platinum Eligible Subgroup | 25 |
| Treatment B - Platinum Eligible Subgroup | 18 |
Reported measurements
Positive
| Group | Source count |
|---|---|
| Treatment A - Platinum Eligible Subgroup | 7 |
| Treatment B - Platinum Eligible Subgroup | 7 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment A - Platinum Eligible Subgroup | 33.84 | Not reported | 4.14 | NA | Insufficient number of events to calculate upper limit number. |
| Treatment B - Platinum Eligible Subgroup | 48.49 | Not reported | 5.49 | NA | Insufficient number of events to calculate upper limit number. |
Negative
| Group | Source count |
|---|---|
| Treatment A - Platinum Eligible Subgroup | 18 |
| Treatment B - Platinum Eligible Subgroup | 11 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment A - Platinum Eligible Subgroup | 27.04 | Not reported | 10.97 | NA | Insufficient number of events to calculate upper limit number. |
| Treatment B - Platinum Eligible Subgroup | 19.32 | Not reported | 4.11 | NA | Insufficient number of events to calculate upper limit number. |
Complete source fields
- classes
- categories
- measurements
- comment
- Insufficient number of events to calculate upper limit number.
- group Id
- OG000
- lower Limit
- 4.14
- upper Limit
- NA
- value
- 33.84
- comment
- Insufficient number of events to calculate upper limit number.
- group Id
- OG001
- lower Limit
- 5.49
- upper Limit
- NA
- value
- 48.49
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- units
- Participants
- title
- Positive
- categories
- measurements
- comment
- Insufficient number of events to calculate upper limit number.
- group Id
- OG000
- lower Limit
- 10.97
- upper Limit
- NA
- value
- 27.04
- comment
- Insufficient number of events to calculate upper limit number.
- group Id
- OG001
- lower Limit
- 4.11
- upper Limit
- NA
- value
- 19.32
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- Negative
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 18
- units
- Participants
- description
- The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
- id
- OG000
- title
- Treatment A - Platinum Eligible Subgroup
- description
- Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
- id
- OG001
- title
- Treatment B - Platinum Eligible Subgroup
- param Type
- MEDIAN
- population Description
- All treated participants in the Platinum Eligible subgroup with a response
- reporting Status
- POSTED
- time Frame
- From randomization to disease progression or death. Approximately 63 Months
- title
- Duration of Response (DOR) - Platinum Eligible Subgroup Based on HPV p-16 Status
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice