TriangleNCT03345485 · OUTCOME
Progression Free Survival (PFS) Time for Phase 2 and Sub Studies
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- From patient's first dose until first documented progression/start of subsequent anti-cancer therapy/death from any cause, whichever came first, up to 26 months.
What was measured
PFS was defined as the number of days between the date of the first dose of treatment of a patient and the first date of disease progression, start of a subsequent anti-cancer therapy, or death of the patient.
Groups in this outcome
Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort
Progression-free survival (PFS) time for patients with small cell lung cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.
Tinostamustine (EDO-S101) - Phase 2 STS Cohort
Progression-free survival (PFS) time for patients with soft tissue sarcoma who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.
Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort
Progression-free survival (PFS) time for patients with triple-negative breast cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.
Tinostamustine (EDO-S101) - Phase 2 OC Cohort
Progression-free survival (PFS) time for patients with ovarian cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.
Tinostamustine (EDO-S101) - Phase 2 EC Cohort
Progression-free survival (PFS) time for patients with endometrial cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)
Progression-free survival (PFS) time for patients with solid tumour who received 60 mg/m2 of EDO-S101 administered over 1 hour
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)
Progression-free survival (PFS) time for patients with solid tumour who received 80 mg/m2 of EDO-S101 administered over 80 minutes
| Group | Source count |
|---|---|
| Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort | 4 |
| Tinostamustine (EDO-S101) - Phase 2 STS Cohort | 10 |
| Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort | 4 |
| Tinostamustine (EDO-S101) - Phase 2 OC Cohort | 12 |
| Tinostamustine (EDO-S101) - Phase 2 EC Cohort | 6 |
| Tinostamustine (EDO-S101) - Sub Study 1 (SS1) | 6 |
| Tinostamustine (EDO-S101) - Sub Study 2 (SS2) | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort | 54.0 | Not reported | 50.0 | NA | Could not be calculated due to insufficient number of participants with events |
| Tinostamustine (EDO-S101) - Phase 2 STS Cohort | 56.0 | Not reported | 50.0 | 236.0 | Not reported |
| Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort | 85.0 | Not reported | 58.0 | NA | Could not be calculated due to insufficient number of participants with events |
| Tinostamustine (EDO-S101) - Phase 2 OC Cohort | 63.0 | Not reported | 44.0 | 97.0 | Not reported |
| Tinostamustine (EDO-S101) - Phase 2 EC Cohort | 87.0 | Not reported | 33.0 | 107.0 | Not reported |
| Tinostamustine (EDO-S101) - Sub Study 1 (SS1) | 177.0 | Not reported | 62.0 | NA | Could not be calculated due to insufficient number of participants with events |
| Tinostamustine (EDO-S101) - Sub Study 2 (SS2) | 65.0 | Not reported | 23.0 | NA | Could not be calculated due to insufficient number of participants with events |
Complete source fields
- classes
- categories
- measurements
- comment
- Could not be calculated due to insufficient number of participants with events
- group Id
- OG000
- lower Limit
- 50.0
- upper Limit
- NA
- value
- 54.0
- group Id
- OG001
- lower Limit
- 50.0
- upper Limit
- 236.0
- value
- 56.0
- comment
- Could not be calculated due to insufficient number of participants with events
- group Id
- OG002
- lower Limit
- 58.0
- upper Limit
- NA
- value
- 85.0
- group Id
- OG003
- lower Limit
- 44.0
- upper Limit
- 97.0
- value
- 63.0
- group Id
- OG004
- lower Limit
- 33.0
- upper Limit
- 107.0
- value
- 87.0
- comment
- Could not be calculated due to insufficient number of participants with events
- group Id
- OG005
- lower Limit
- 62.0
- upper Limit
- NA
- value
- 177.0
- comment
- Could not be calculated due to insufficient number of participants with events
- group Id
- OG006
- lower Limit
- 23.0
- upper Limit
- NA
- value
- 65.0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 7
- units
- Participants
- description
- PFS was defined as the number of days between the date of the first dose of treatment of a patient and the first date of disease progression, start of a subsequent anti-cancer therapy, or death of the patient.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Progression-free survival (PFS) time for patients with small cell lung cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.
- id
- OG000
- title
- Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort
- description
- Progression-free survival (PFS) time for patients with soft tissue sarcoma who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.
- id
- OG001
- title
- Tinostamustine (EDO-S101) - Phase 2 STS Cohort
- description
- Progression-free survival (PFS) time for patients with triple-negative breast cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.
- id
- OG002
- title
- Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort
- description
- Progression-free survival (PFS) time for patients with ovarian cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.
- id
- OG003
- title
- Tinostamustine (EDO-S101) - Phase 2 OC Cohort
- description
- Progression-free survival (PFS) time for patients with endometrial cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.
- id
- OG004
- title
- Tinostamustine (EDO-S101) - Phase 2 EC Cohort
- description
- Progression-free survival (PFS) time for patients with solid tumour who received 60 mg/m2 of EDO-S101 administered over 1 hour
- id
- OG005
- title
- Tinostamustine (EDO-S101) - Sub Study 1 (SS1)
- description
- Progression-free survival (PFS) time for patients with solid tumour who received 80 mg/m2 of EDO-S101 administered over 80 minutes
- id
- OG006
- title
- Tinostamustine (EDO-S101) - Sub Study 2 (SS2)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- From patient's first dose until first documented progression/start of subsequent anti-cancer therapy/death from any cause, whichever came first, up to 26 months.
- title
- Progression Free Survival (PFS) Time for Phase 2 and Sub Studies
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice