TriangleNCT04075721 · OUTCOME
Part A: Change From Baseline in 12-lead Electrocardiogram (ECG) Findings: QT Interval - Fridericia's Correction Formula
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- milliseconds (msec)
- Interval / dispersion
- Full Range
- Time frame
- Cycle 1 Day 1 pre-dose (Baseline), pre-dose on Cycle 2 Day 1 (each Cycle is of 28 days)
What was measured
12-lead ECG were recorded after the participants have rested for at least 15 minutes in supine position. Change from baseline in 12-Lead ECG findings that is QT interval - Fridericia's correction formula at pre-dose on Cycle 2 Day 1 were reported.
Analysis population: Safety analysis set included all participants who were administered any dose of the study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Groups in this outcome
M3258 10 mg QD
Participants received M3258 at a dose of 10 milligrams (mg) orally, once daily (QD) until disease progression.
M3258 10 mg Twice Per Week
Participants received M3258 at a dose of 10 mg orally, twice per week on Day 1 and Day 4 until disease progression.
M3258 20 mg Twice Per Week
Participants received M3258 at a dose of 20 mg orally, twice per week on Day 1 and Day 4 until disease progression.
| Group | Source count |
|---|---|
| M3258 10 mg QD | 1 |
| M3258 10 mg Twice Per Week | 3 |
| M3258 20 mg Twice Per Week | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| M3258 10 mg QD | -10.0 | -10 | -10 | -10 | Not reported |
| M3258 10 mg Twice Per Week | 6.3 | -17 | -17 | 45 | Not reported |
| M3258 20 mg Twice Per Week | 6.0 | 6 | 6 | 6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -10
- spread
- -10
- upper Limit
- -10
- value
- -10.0
- group Id
- OG001
- lower Limit
- -17
- spread
- -17
- upper Limit
- 45
- value
- 6.3
- group Id
- OG002
- lower Limit
- 6
- spread
- 6
- upper Limit
- 6
- value
- 6.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- units
- Participants
- description
- 12-lead ECG were recorded after the participants have rested for at least 15 minutes in supine position. Change from baseline in 12-Lead ECG findings that is QT interval - Fridericia's correction formula at pre-dose on Cycle 2 Day 1 were reported.
- dispersion Type
- Full Range
- groups
- description
- Participants received M3258 at a dose of 10 milligrams (mg) orally, once daily (QD) until disease progression.
- id
- OG000
- title
- M3258 10 mg QD
- description
- Participants received M3258 at a dose of 10 mg orally, twice per week on Day 1 and Day 4 until disease progression.
- id
- OG001
- title
- M3258 10 mg Twice Per Week
- description
- Participants received M3258 at a dose of 20 mg orally, twice per week on Day 1 and Day 4 until disease progression.
- id
- OG002
- title
- M3258 20 mg Twice Per Week
- param Type
- MEAN
- population Description
- Safety analysis set included all participants who were administered any dose of the study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 pre-dose (Baseline), pre-dose on Cycle 2 Day 1 (each Cycle is of 28 days)
- title
- Part A: Change From Baseline in 12-lead Electrocardiogram (ECG) Findings: QT Interval - Fridericia's Correction Formula
- type
- PRIMARY
- unit Of Measure
- milliseconds (msec)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice