TriangleNCT00586924 · OUTCOME
Duration of Complete Response
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
Duration of CR was measured from the first documentation of CR to the first documented non-CR and was evaluated in participants who had achieved an CR. Duration of CR were 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. Here, the "Overall Number of Participants Analyzed" denotes the number of participants who had achieved CR and had the first documented non-CR till end of the study.
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 | 0 |
| 10 mcg/kg | 1 |
| 20 mcg/kg | 1 |
| 30 mcg/kg | 1 |
| 40 mcg/kg | 0 |
| 50 mcg/kg | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mcg/kg | NA | Not reported | NA | NA | Not estimable because insufficient number of participants have events (progressed or relapsed). |
| 20 mcg/kg | 25.89 | Not reported | NA | NA | Not estimable because insufficient number of participants have events (progressed or relapsed). |
| 30 mcg/kg | 70.34 | Not reported | NA | NA | Not estimable because insufficient number of participants have events (progressed or relapsed). |
| 50 mcg/kg | 42.35 | Not reported | 17.45 | 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
- 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
- 25.89
- comment
- Not estimable because insufficient number of participants have events (progressed or relapsed).
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- 70.34
- comment
- Not estimable because insufficient number of participants have events (progressed or relapsed).
- group Id
- OG005
- lower Limit
- 17.45
- upper Limit
- NA
- value
- 42.35
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 9
- units
- Participants
- description
- Duration of CR was measured from the first documentation of CR to the first documented non-CR and was evaluated in participants who had achieved an CR. Duration of CR were 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. Here, the "Overall Number of Participants Analyzed" denotes the number of participants who had achieved CR and had the first documented non-CR till end of the study.
- 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
- Duration of Complete Response
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice