NCT03395080 · OUTCOME
Progression-free Survival (PFS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
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
- Baseline to study completion (maximum 7.1 months)
What was measured
Progression-free survival (PFS) is defined as time from first dose of study drug to first documentation of PD (per RECIST 1.1) or death due to any cause.
Analysis population: Full Analysis Set (FAS), all subjects who received any amount of DKN-01.
Groups in this outcome
DKN-01 Monotherapy in Recurrent EEC
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EEC
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 Monotherapy in Recurrent EOC
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EOC
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 300mg Monotherapy in Carcinosarcoma
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 600mg Monotherapy in Carcinosarcoma
600mg DKN-01 onotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 300mg + Paclitaxel in Carcinosarcoma
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 600mg + Paclitaxel in Carcinosarcoma
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
| Group | Source count |
|---|---|
| DKN-01 Monotherapy in Recurrent EEC | 29 |
| DKN-01 + Paclitaxel in Recurrent EEC | 24 |
| DKN-01 Monotherapy in Recurrent EOC | 14 |
| DKN-01 + Paclitaxel in Recurrent EOC | 19 |
| DKN-01 300mg Monotherapy in Carcinosarcoma | 1 |
| DKN-01 600mg Monotherapy in Carcinosarcoma | 8 |
| DKN-01 300mg + Paclitaxel in Carcinosarcoma | 4 |
| DKN-01 600mg + Paclitaxel in Carcinosarcoma | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| DKN-01 Monotherapy in Recurrent EEC | 1.8 | Not reported | 1.7 | 5.5 | Not reported |
| DKN-01 + Paclitaxel in Recurrent EEC | 3.8 | Not reported | 1.8 | 5.4 | Not reported |
| DKN-01 Monotherapy in Recurrent EOC | 2.1 | Not reported | 1.6 | 3.5 | Not reported |
| DKN-01 + Paclitaxel in Recurrent EOC | 3.6 | Not reported | 1.8 | 7.1 | Not reported |
| DKN-01 300mg Monotherapy in Carcinosarcoma | 11.6 | Not reported | NA | NA | NA=not estimable. Data are not estimable due to insufficient number of participants with events. |
| DKN-01 600mg Monotherapy in Carcinosarcoma | 1.6 | Not reported | 0.5 | 7.9 | Not reported |
| DKN-01 300mg + Paclitaxel in Carcinosarcoma | 2.0 | Not reported | 1.8 | 5.5 | Not reported |
| DKN-01 600mg + Paclitaxel in Carcinosarcoma | 1.9 | Not reported | 0.9 | 4.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.7
- upper Limit
- 5.5
- value
- 1.8
- group Id
- OG001
- lower Limit
- 1.8
- upper Limit
- 5.4
- value
- 3.8
- group Id
- OG002
- lower Limit
- 1.6
- upper Limit
- 3.5
- value
- 2.1
- group Id
- OG003
- lower Limit
- 1.8
- upper Limit
- 7.1
- value
- 3.6
- comment
- NA=not estimable. Data are not estimable due to insufficient number of participants with events.
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- 11.6
- group Id
- OG005
- lower Limit
- 0.5
- upper Limit
- 7.9
- value
- 1.6
- group Id
- OG006
- lower Limit
- 1.8
- upper Limit
- 5.5
- value
- 2.0
- group Id
- OG007
- lower Limit
- 0.9
- upper Limit
- 4.0
- value
- 1.9
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 10
- units
- Participants
- description
- Progression-free survival (PFS) is defined as time from first dose of study drug to first documentation of PD (per RECIST 1.1) or death due to any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
- id
- OG000
- title
- DKN-01 Monotherapy in Recurrent EEC
- description
- 300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
- id
- OG001
- title
- DKN-01 + Paclitaxel in Recurrent EEC
- description
- 300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
- id
- OG002
- title
- DKN-01 Monotherapy in Recurrent EOC
- description
- 300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
- id
- OG003
- title
- DKN-01 + Paclitaxel in Recurrent EOC
- description
- 300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
- id
- OG004
- title
- DKN-01 300mg Monotherapy in Carcinosarcoma
- description
- 600mg DKN-01 onotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
- id
- OG005
- title
- DKN-01 600mg Monotherapy in Carcinosarcoma
- description
- 300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
- id
- OG006
- title
- DKN-01 300mg + Paclitaxel in Carcinosarcoma
- description
- 600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
- id
- OG007
- title
- DKN-01 600mg + Paclitaxel in Carcinosarcoma
- param Type
- MEDIAN
- population Description
- Full Analysis Set (FAS), all subjects who received any amount of DKN-01.
- reporting Status
- POSTED
- time Frame
- Baseline to study completion (maximum 7.1 months)
- title
- Progression-free Survival (PFS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice
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