TriangleNCT03345485 · OUTCOME
Highest Change From Baseline in QTcF in Sub-studies
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- msec
- Interval / dispersion
- Standard Deviation
- Time frame
- From cycle 1 and at every cycle on treatment days D1 and D15, assessed pre-dose and post-start of infusion at 30 and 80mins (Substudy 2 - up to 6 months) and 30, 60, 90, 120 and 180mins (substudy 1 - up to 6 months).
What was measured
QTcF: corrected QT interval \[QTc\] using Fridericia's formula) and other electrocardiogram (ECG) parameters in subjects with solid tumours who have progressed after at least 1 line of therapy and for whom no other standard therapy with proven clinical benefit is available. Within each cycle a Change from baseline (CfB) is calculated for QTcF relative to the baseline value of day 1 of the cycle. QTcF CfB= QTcF Post-dose value - QTcF pre-dose value of D1 ECG Parameters: 4-hours ECG holter monitoring in C1 and ECGs during EDO-S101 administration. Continuous variables the mean and standard deviation are presented together with the total number of observations and the number of missing and non-missing values.
Groups in this outcome
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)
6 Patients treated with 60 mg/m2 as a single agent of Tinostamustine administered over 60 minutes infusion time
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)
7 Patients treated with 80 mg/m2 as a single agent of Tinostamustine administered over 80 minutes infusion time
| Group | Source count |
|---|---|
| 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) - Sub Study 1 (SS1) | 53.33 | 23.777 | Not reported | Not reported | Not reported |
| Tinostamustine (EDO-S101) - Sub Study 2 (SS2) | 33.24 | 12.588 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 23.777
- value
- 53.33
- group Id
- OG001
- spread
- 12.588
- value
- 33.24
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- QTcF: corrected QT interval \[QTc\] using Fridericia's formula) and other electrocardiogram (ECG) parameters in subjects with solid tumours who have progressed after at least 1 line of therapy and for whom no other standard therapy with proven clinical benefit is available. Within each cycle a Change from baseline (CfB) is calculated for QTcF relative to the baseline value of day 1 of the cycle. QTcF CfB= QTcF Post-dose value - QTcF pre-dose value of D1 ECG Parameters: 4-hours ECG holter monitoring in C1 and ECGs during EDO-S101 administration. Continuous variables the mean and standard deviation are presented together with the total number of observations and the number of missing and non-missing values.
- dispersion Type
- Standard Deviation
- groups
- description
- 6 Patients treated with 60 mg/m2 as a single agent of Tinostamustine administered over 60 minutes infusion time
- id
- OG000
- title
- Tinostamustine (EDO-S101) - Sub Study 1 (SS1)
- description
- 7 Patients treated with 80 mg/m2 as a single agent of Tinostamustine administered over 80 minutes infusion time
- id
- OG001
- title
- Tinostamustine (EDO-S101) - Sub Study 2 (SS2)
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- From cycle 1 and at every cycle on treatment days D1 and D15, assessed pre-dose and post-start of infusion at 30 and 80mins (Substudy 2 - up to 6 months) and 30, 60, 90, 120 and 180mins (substudy 1 - up to 6 months).
- title
- Highest Change From Baseline in QTcF in Sub-studies
- type
- PRIMARY
- unit Of Measure
- msec
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Preserved source evidence · Not medical advice