TriangleNCT00441337 · OUTCOME
Time to Tumor Progression and Tumor Progression Free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 1 to 2 Years
What was measured
Time to tumor progression (TTP) was measured in days from date of the first dose to the date of the first PD or the date of death if due to PD. For those who died without PD it was censored at the date of death. TTP was censored at the last tumor assessment by the end of study if a participant did not have PD or death. Tumor progression free survival (PFS) was measured in days from the date of first dose to the date of the first disease progression or to the date of death. PFS was censored at the last tumor assessment date by the end of study if a participant did not have PD or death.
Analysis population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.
Groups in this outcome
0.3 mg/kg Nivolumab
0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg/kg Nivolumab
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg/kg Nivolumab
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg/kg Nivolumab
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
| Group | Source count |
|---|---|
| 0.3 mg/kg Nivolumab | 6 |
| 1 mg/kg Nivolumab | 6 |
| 3 mg/kg Nivolumab | 6 |
| 10 mg/kg Nivolumab | 21 |
Reported measurements
Time to Tumor Progression
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 mg/kg Nivolumab | 56 | Not reported | 51 | 57 | Not reported |
| 1 mg/kg Nivolumab | 57.5 | Not reported | 57 | 59 | Not reported |
| 3 mg/kg Nivolumab | 86 | Not reported | 57 | 193 | Not reported |
| 10 mg/kg Nivolumab | 57 | Not reported | 53 | 85 | Not reported |
Tumor Progression Free Survival
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 mg/kg Nivolumab | 56 | Not reported | 51 | 57 | Not reported |
| 1 mg/kg Nivolumab | 57.5 | Not reported | 57 | 59 | Not reported |
| 3 mg/kg Nivolumab | 86 | Not reported | 57 | 193 | Not reported |
| 10 mg/kg Nivolumab | 57 | Not reported | 53 | 85 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 51
- upper Limit
- 57
- value
- 56
- group Id
- OG001
- lower Limit
- 57
- upper Limit
- 59
- value
- 57.5
- group Id
- OG002
- lower Limit
- 57
- upper Limit
- 193
- value
- 86
- group Id
- OG003
- lower Limit
- 53
- upper Limit
- 85
- value
- 57
- title
- Time to Tumor Progression
- categories
- measurements
- group Id
- OG000
- lower Limit
- 51
- upper Limit
- 57
- value
- 56
- group Id
- OG001
- lower Limit
- 57
- upper Limit
- 59
- value
- 57.5
- group Id
- OG002
- lower Limit
- 57
- upper Limit
- 193
- value
- 86
- group Id
- OG003
- lower Limit
- 53
- upper Limit
- 85
- value
- 57
- title
- Tumor Progression Free Survival
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 21
- units
- Participants
- description
- Time to tumor progression (TTP) was measured in days from date of the first dose to the date of the first PD or the date of death if due to PD. For those who died without PD it was censored at the date of death. TTP was censored at the last tumor assessment by the end of study if a participant did not have PD or death. Tumor progression free survival (PFS) was measured in days from the date of first dose to the date of the first disease progression or to the date of death. PFS was censored at the last tumor assessment date by the end of study if a participant did not have PD or death.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
- id
- OG000
- title
- 0.3 mg/kg Nivolumab
- description
- 1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
- id
- OG001
- title
- 1 mg/kg Nivolumab
- description
- 3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
- id
- OG002
- title
- 3 mg/kg Nivolumab
- description
- 10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
- id
- OG003
- title
- 10 mg/kg Nivolumab
- param Type
- MEDIAN
- population Description
- All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.
- reporting Status
- POSTED
- time Frame
- Day 1 to 2 Years
- title
- Time to Tumor Progression and Tumor Progression Free Survival
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice