TriangleNCT01412957 · OUTCOME
Maximum Post-baseline Change From Baseline in Corrected QT (QTc) Interval
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
- Baseline (pre-dose), Week 1 and Week 7 (post-dose) and 4 weeks after the last dose (Safety Follow-up visit)
What was measured
QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle as measured by electrocardiogram (ECG). QTc is the QT interval corrected for heart rate. To evaluate the effect of panitumumab treatment on the QTc interval length among participants treated with panitumumab, ECGs were collected at the following time points from participants randomized to panitumumab arm at a limited number of sites: Week 1 prior to the first panitumumab infusion (Baseline) and within 30 minutes following the end of the first infusion of panitumumab (Cmax), Week 7 after 3 doses of panitumumab (steady state), and at the safety follow-up visit. The ECGs were submitted for independent central review to calculate the reported QTc interval. QTc was calculated using both the Bazett correction (QTcB) and the Fridericia correction (QTcF).
Analysis population: QTc Analysis Set is defined as the subset of participants in the Safety Analysis Set who received at least one panitumumab dose and were enrolled at the limited number of sites participating in QTc evaluation and had baseline and at least 1 post-baseline QTc assessment.
Groups in this outcome
Panitumumab + BSC
Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
BSC Alone
Participants received best supportive care until disease progression, withdrawal of consent, or death.
| Group | Source count |
|---|---|
| Panitumumab + BSC | 53 |
| BSC Alone | 0 |
Reported measurements
QTcF
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Panitumumab + BSC | 14.58 | 13.60 | Not reported | Not reported | Not reported |
QTcB
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Panitumumab + BSC | 12.57 | 12.15 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 13.60
- value
- 14.58
- title
- QTcF
- categories
- measurements
- group Id
- OG000
- spread
- 12.15
- value
- 12.57
- title
- QTcB
- denoms
- counts
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle as measured by electrocardiogram (ECG). QTc is the QT interval corrected for heart rate. To evaluate the effect of panitumumab treatment on the QTc interval length among participants treated with panitumumab, ECGs were collected at the following time points from participants randomized to panitumumab arm at a limited number of sites: Week 1 prior to the first panitumumab infusion (Baseline) and within 30 minutes following the end of the first infusion of panitumumab (Cmax), Week 7 after 3 doses of panitumumab (steady state), and at the safety follow-up visit. The ECGs were submitted for independent central review to calculate the reported QTc interval. QTc was calculated using both the Bazett correction (QTcB) and the Fridericia correction (QTcF).
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
- id
- OG000
- title
- Panitumumab + BSC
- description
- Participants received best supportive care until disease progression, withdrawal of consent, or death.
- id
- OG001
- title
- BSC Alone
- param Type
- MEAN
- population Description
- QTc Analysis Set is defined as the subset of participants in the Safety Analysis Set who received at least one panitumumab dose and were enrolled at the limited number of sites participating in QTc evaluation and had baseline and at least 1 post-baseline QTc assessment.
- reporting Status
- POSTED
- time Frame
- Baseline (pre-dose), Week 1 and Week 7 (post-dose) and 4 weeks after the last dose (Safety Follow-up visit)
- title
- Maximum Post-baseline Change From Baseline in Corrected QT (QTc) Interval
- type
- SECONDARY
- unit Of Measure
- msec
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice