NCT03345485 · OUTCOME
Maximum Duration of Response (DoR) 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
- NUMBER
- Unit
- days
- Interval / dispersion
- Not reported
- Time frame
- From patient's first overall response of CR or PR, until disease progression/subsequent anti-cancer therapy/death from any cause, up to 24 months.
What was measured
The duration of objective response is measured from the date of the first tumor response assessment with an Investigator's Overall Response of CR or PR (whichever status is recorded first) until the date of progression or death. DoR is presented by subject.
Analysis population: Number of participants is zero in some of the arms as no participants achieved a response of CR or PR.
Groups in this outcome
Tinostamustine (EDO-S101) - Phase 2 STS Cohort
Duration of response for patients with soft tissue sarcoma cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour.
Tinostamustine (EDO-S101) - Phase 2 OC Cohort
Duration of response for patients with ovarian cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour.
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)
Duration of response for patients with solid tumour who received 60 mg/m2 of EDO-S101 administered over 1 hour.
| Group | Source count |
|---|---|
| Tinostamustine (EDO-S101) - Phase 2 STS Cohort | 1 |
| Tinostamustine (EDO-S101) - Phase 2 OC Cohort | 1 |
| Tinostamustine (EDO-S101) - Sub Study 1 (SS1) | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tinostamustine (EDO-S101) - Phase 2 STS Cohort | 51 | Not reported | Not reported | Not reported | Not reported |
| Tinostamustine (EDO-S101) - Phase 2 OC Cohort | 52 | Not reported | Not reported | Not reported | Not reported |
| Tinostamustine (EDO-S101) - Sub Study 1 (SS1) | 734 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 52
- group Id
- OG002
- value
- 734
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- units
- Participants
- description
- The duration of objective response is measured from the date of the first tumor response assessment with an Investigator's Overall Response of CR or PR (whichever status is recorded first) until the date of progression or death. DoR is presented by subject.
- groups
- description
- Duration of response for patients with soft tissue sarcoma cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour.
- id
- OG000
- title
- Tinostamustine (EDO-S101) - Phase 2 STS Cohort
- description
- Duration of response for patients with ovarian cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour.
- id
- OG001
- title
- Tinostamustine (EDO-S101) - Phase 2 OC Cohort
- description
- Duration of response for patients with solid tumour who received 60 mg/m2 of EDO-S101 administered over 1 hour.
- id
- OG002
- title
- Tinostamustine (EDO-S101) - Sub Study 1 (SS1)
- param Type
- NUMBER
- population Description
- Number of participants is zero in some of the arms as no participants achieved a response of CR or PR.
- reporting Status
- POSTED
- time Frame
- From patient's first overall response of CR or PR, until disease progression/subsequent anti-cancer therapy/death from any cause, up to 24 months.
- title
- Maximum Duration of Response (DoR) Time for Phase 2 and Sub Studies
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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