TriangleNCT00586924 · OUTCOME
Progression-free Survival (PFS)
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 Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)
What was measured
PFS was measured from the start of moxetumomab pasudotox treatment until the first documentation of disease progression/relapse or death, whichever occurred first. PFS was summarized using Kaplan-Meier estimates (median time, 95% CI for median time).
Analysis population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
Groups in this outcome
5 mcg/kg
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
10 mcg/kg
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
20 mcg/kg
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
30 mcg/kg
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
40 mcg/kg
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
50 mcg/kg
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
| Group | Source count |
|---|---|
| 5 mcg/kg | 3 |
| 10 mcg/kg | 3 |
| 20 mcg/kg | 3 |
| 30 mcg/kg | 3 |
| 40 mcg/kg | 4 |
| 50 mcg/kg | 33 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 5 mcg/kg | 11.33 | Not reported | NA | NA | Not estimable because insufficient number of participants have events (progressed or relapsed). |
| 10 mcg/kg | NA | Not reported | NA | NA | Not estimable because insufficient number of participants have events (progressed or relapsed). |
| 20 mcg/kg | NA | Not reported | NA | NA | Not estimable because insufficient number of participants have events (progressed or relapsed). |
| 30 mcg/kg | 82.07 | Not reported | 2.00 | 82.07 | Not reported |
| 40 mcg/kg | NA | Not reported | 0.92 | NA | Not estimable because insufficient number of participants have events (progressed or relapsed). |
| 50 mcg/kg | NA | Not reported | NA | NA | Not estimable because insufficient number of participants have events (progressed or relapsed). |
Complete source fields
- classes
- categories
- measurements
- comment
- Not estimable because insufficient number of participants have events (progressed or relapsed).
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 11.33
- comment
- Not estimable because insufficient number of participants have events (progressed or relapsed).
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Not estimable because insufficient number of participants have events (progressed or relapsed).
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG003
- lower Limit
- 2.00
- upper Limit
- 82.07
- value
- 82.07
- comment
- Not estimable because insufficient number of participants have events (progressed or relapsed).
- group Id
- OG004
- lower Limit
- 0.92
- upper Limit
- NA
- value
- NA
- comment
- Not estimable because insufficient number of participants have events (progressed or relapsed).
- group Id
- OG005
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 33
- units
- Participants
- description
- PFS was measured from the start of moxetumomab pasudotox treatment until the first documentation of disease progression/relapse or death, whichever occurred first. PFS was summarized using Kaplan-Meier estimates (median time, 95% CI for median time).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG000
- title
- 5 mcg/kg
- description
- Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG001
- title
- 10 mcg/kg
- description
- Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG002
- title
- 20 mcg/kg
- description
- Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG003
- title
- 30 mcg/kg
- description
- Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG004
- title
- 40 mcg/kg
- description
- Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG005
- title
- 50 mcg/kg
- param Type
- MEDIAN
- population Description
- Safety population included all participants who received any treatment of moxetumomab pasudotox.
- reporting Status
- POSTED
- time Frame
- From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)
- title
- Progression-free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice