NCT02598661 · OUTCOME
QTc Substudy: Change From Baseline in QT Interval by Fridericia's Correction Method (ΔQTcF)
Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) · Source last updated 2026-07-17
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- milliseconds (ms)
- Interval / dispersion
- Standard Error
- Time frame
- Baseline, Cycle 1, Day 1: 0.5, 1, 2, 4, 6, and 8 hours post-dose (cycle length= 28 days)
What was measured
Baseline was defined as the mean of the measured ECG intervals collected at 3 time points (-1 hour, -0.5 hour, and 0 hour) prior to treatment administration on Cycle 1 Day 1 (Cycle length= 28 days)
Analysis population: The QTc substudy analysis set included all participants who participated in QTc substudy and received at least one dose of study drug, with measurements at baseline as well as on-treatment with at least 1 post-dose time point with a ΔQTcF value. By-time Point Analysis Set included each post-baseline time point that had a non-missing change-from-baseline observation. Number analysed is the number of participants with data available for analysis at specified timepoints.
Groups in this outcome
QTc Substudy: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
QTc Substudy: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. If after a minimum of 2 treatment cycles a participant has no significant change to pRBC transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant, he/she may be permitted to start treatment with imetelstat sodium.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| QTc Substudy: Imetelstat Sodium | 29 |
|---|
| QTc Substudy: Placebo | 16 |
|---|
Reported measurements
Change at 0.5 hr post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| QTc Substudy: Imetelstat Sodium | 29 |
|---|
| QTc Substudy: Placebo | 16 |
|---|
Values in milliseconds (ms) · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| QTc Substudy: Imetelstat Sodium | 4.2 | 1.54 | Not reported | Not reported | Not reported |
|---|
| QTc Substudy: Placebo | 1.9 | 2.09 | Not reported | Not reported | Not reported |
|---|
Change at 1 hr post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| QTc Substudy: Imetelstat Sodium | 29 |
|---|
| QTc Substudy: Placebo | 16 |
|---|
Values in milliseconds (ms) · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| QTc Substudy: Imetelstat Sodium | 5.4 | 1.47 | Not reported | Not reported | Not reported |
|---|
| QTc Substudy: Placebo | 0.4 | 2.00 | Not reported | Not reported | Not reported |
|---|
Change at 2 hr post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| QTc Substudy: Imetelstat Sodium | 29 |
|---|
| QTc Substudy: Placebo | 16 |
|---|
Values in milliseconds (ms) · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| QTc Substudy: Imetelstat Sodium | 5.5 | 1.56 | Not reported | Not reported | Not reported |
|---|
| QTc Substudy: Placebo | 3.7 | 2.12 | Not reported | Not reported | Not reported |
|---|
Change at 4 hr post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| QTc Substudy: Imetelstat Sodium | 29 |
|---|
| QTc Substudy: Placebo | 16 |
|---|
Values in milliseconds (ms) · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| QTc Substudy: Imetelstat Sodium | 1.8 | 2.43 | Not reported | Not reported | Not reported |
|---|
| QTc Substudy: Placebo | 1.1 | 3.28 | Not reported | Not reported | Not reported |
|---|
Change at 6 hr post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| QTc Substudy: Imetelstat Sodium | 26 |
|---|
| QTc Substudy: Placebo | 16 |
|---|
Values in milliseconds (ms) · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| QTc Substudy: Imetelstat Sodium | 1.7 | 2.37 | Not reported | Not reported | Not reported |
|---|
| QTc Substudy: Placebo | -1.1 | 3.12 | Not reported | Not reported | Not reported |
|---|
Change at 8 hr post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| QTc Substudy: Imetelstat Sodium | 26 |
|---|
| QTc Substudy: Placebo | 15 |
|---|
Values in milliseconds (ms) · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| QTc Substudy: Imetelstat Sodium | 2.3 | 2.53 | Not reported | Not reported | Not reported |
|---|
| QTc Substudy: Placebo | -3.4 | 3.36 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.54
- value
- 4.2
- group Id
- OG001
- spread
- 2.09
- value
- 1.9
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 16
- units
- Participants
- title
- Change at 0.5 hr post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 1.47
- value
- 5.4
- group Id
- OG001
- spread
- 2.00
- value
- 0.4
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 16
- units
- Participants
- title
- Change at 1 hr post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 1.56
- value
- 5.5
- group Id
- OG001
- spread
- 2.12
- value
- 3.7
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 16
- units
- Participants
- title
- Change at 2 hr post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 2.43
- value
- 1.8
- group Id
- OG001
- spread
- 3.28
- value
- 1.1
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 16
- units
- Participants
- title
- Change at 4 hr post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 2.37
- value
- 1.7
- group Id
- OG001
- spread
- 3.12
- value
- -1.1
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 16
- units
- Participants
- title
- Change at 6 hr post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 2.53
- value
- 2.3
- group Id
- OG001
- spread
- 3.36
- value
- -3.4
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 15
- units
- Participants
- title
- Change at 8 hr post-dose
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 16
- units
- Participants
- description
- Baseline was defined as the mean of the measured ECG intervals collected at 3 time points (-1 hour, -0.5 hour, and 0 hour) prior to treatment administration on Cycle 1 Day 1 (Cycle length= 28 days)
- dispersion Type
- Standard Error
- groups
- description
- Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
- id
- OG000
- title
- QTc Substudy: Imetelstat Sodium
- description
- Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. If after a minimum of 2 treatment cycles a participant has no significant change to pRBC transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant, he/she may be permitted to start treatment with imetelstat sodium.
- id
- OG001
- title
- QTc Substudy: Placebo
- param Type
- LEAST_SQUARES_MEAN
- population Description
- The QTc substudy analysis set included all participants who participated in QTc substudy and received at least one dose of study drug, with measurements at baseline as well as on-treatment with at least 1 post-dose time point with a ΔQTcF value. By-time Point Analysis Set included each post-baseline time point that had a non-missing change-from-baseline observation. Number analysed is the number of participants with data available for analysis at specified timepoints.
- reporting Status
- POSTED
- time Frame
- Baseline, Cycle 1, Day 1: 0.5, 1, 2, 4, 6, and 8 hours post-dose (cycle length= 28 days)
- title
- QTc Substudy: Change From Baseline in QT Interval by Fridericia's Correction Method (ΔQTcF)
- type
- SECONDARY
- unit Of Measure
- milliseconds (ms)
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