NCT00441337 · OUTCOME
Mean Change From Baseline in Electrocardiogram Parameters PR, QRS and QT in Safety Population
A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies · Source last updated 2015-02-20
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, Day 2, Day 85, Day 113
What was measured
12-lead ECGs were performed at screening, baseline, Day 2 and at completion of the dose cycle (Day 85 in first dose cycle). In those participants undergoing re-treatment, ECG was repeated at the completion of the re-treatment. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. PR, QRS and QT interval were measured in milliseconds (msec).
Analysis population: All participants who received at least 1 dose or any partial dose of nivolumab and had available ECG at baseline and on the specified post treatment study day were analyzed.
Groups in this outcome
0.3 mg/kg Nivolumab
0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg/kg Nivolumab
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg/kg Nivolumab
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg/kg Nivolumab
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
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 |
|---|
| 0.3 mg/kg Nivolumab | 6 |
|---|
| 1 mg/kg Nivolumab | 6 |
|---|
| 3 mg/kg Nivolumab | 6 |
|---|
| 10 mg/kg Nivolumab | 21 |
|---|
Reported measurements
PR at Day 2 (n=6,6,6,21)
Values in msec · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 0.3 mg/kg Nivolumab | 7.3 | 6.15 | Not reported | Not reported | Not reported |
|---|
| 1 mg/kg Nivolumab | -9.7 | 10.31 | Not reported | Not reported | Not reported |
|---|
| 3 mg/kg Nivolumab | -1.7 | 9.75 | Not reported | Not reported | Not reported |
|---|
| 10 mg/kg Nivolumab | -0.3 | 13.72 | Not reported | Not reported | Not reported |
|---|
QRS at Day 2 (n=6,6,6,21)
Values in msec · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 0.3 mg/kg Nivolumab | 5.0 | 6.90 | Not reported | Not reported | Not reported |
|---|
| 1 mg/kg Nivolumab | -2.0 | 7.48 | Not reported | Not reported | Not reported |
|---|
| 3 mg/kg Nivolumab | -8.7 | 19.83 | Not reported | Not reported | Not reported |
|---|
| 10 mg/kg Nivolumab | -1.2 | 5.57 | Not reported | Not reported | Not reported |
|---|
QT at Day 2 (n=6,6,6,21)
Values in msec · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 0.3 mg/kg Nivolumab | 2.0 | 27.86 | Not reported | Not reported | Not reported |
|---|
| 1 mg/kg Nivolumab | -15.7 | 22.89 | Not reported | Not reported | Not reported |
|---|
| 3 mg/kg Nivolumab | -2.0 | 15.90 | Not reported | Not reported | Not reported |
|---|
| 10 mg/kg Nivolumab | -10.1 | 20.76 | Not reported | Not reported | Not reported |
|---|
PR at Day 57 (n=0,0,0,3)
Values in msec · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 0.3 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 1 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 3 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 10 mg/kg Nivolumab | -11.3 | 24.11 | Not reported | Not reported | Not reported |
|---|
QRS at Day 57 (n=0,0,0,3)
Values in msec · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 0.3 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 1 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 3 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 10 mg/kg Nivolumab | 1.3 | 5.03 | Not reported | Not reported | Not reported |
|---|
QT at Day 57 (n=0,0,0,3)
Values in msec · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 0.3 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 1 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 3 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 10 mg/kg Nivolumab | 5.3 | 33.61 | Not reported | Not reported | Not reported |
|---|
PR at Day 85 (n=0,4,4,11)
Values in msec · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 0.3 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 1 mg/kg Nivolumab | -4.5 | 11.82 | Not reported | Not reported | Not reported |
|---|
| 3 mg/kg Nivolumab | 3.5 | 17.69 | Not reported | Not reported | Not reported |
|---|
| 10 mg/kg Nivolumab | -1.1 | 17.44 | Not reported | Not reported | Not reported |
|---|
QRS at Day 85 (n=0,4,4,11)
Values in msec · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 0.3 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 1 mg/kg Nivolumab | -6.0 | 9.09 | Not reported | Not reported | Not reported |
|---|
| 3 mg/kg Nivolumab | -4.0 | 6.73 | Not reported | Not reported | Not reported |
|---|
| 10 mg/kg Nivolumab | 0.2 | 4.24 | Not reported | Not reported | Not reported |
|---|
QT at Day 85 (n=0,4,4,11)
Values in msec · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 0.3 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 1 mg/kg Nivolumab | -6.0 | 27.90 | Not reported | Not reported | Not reported |
|---|
| 3 mg/kg Nivolumab | -3.5 | 33.52 | Not reported | Not reported | Not reported |
|---|
| 10 mg/kg Nivolumab | -0.2 | 26.40 | Not reported | Not reported | Not reported |
|---|
PR at Day 113 (n=0,0,2,3)
Values in msec · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 0.3 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 1 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 3 mg/kg Nivolumab | 11.0 | 24.04 | Not reported | Not reported | Not reported |
|---|
| 10 mg/kg Nivolumab | 3.3 | 4.62 | Not reported | Not reported | Not reported |
|---|
QRS at Day 113 (n=0,0,2,3)
Values in msec · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 0.3 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 1 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 3 mg/kg Nivolumab | 4.0 | 2.83 | Not reported | Not reported | Not reported |
|---|
| 10 mg/kg Nivolumab | 6.0 | 6.93 | Not reported | Not reported | Not reported |
|---|
QT at Day 113 (n=0,0,2,3)
Values in msec · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 0.3 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 1 mg/kg Nivolumab | NA | NA | Not reported | Not reported | no participants with data on this day in this arm |
|---|
| 3 mg/kg Nivolumab | 4.0 | 50.91 | Not reported | Not reported | Not reported |
|---|
| 10 mg/kg Nivolumab | 6.0 | 28.00 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 6.15
- value
- 7.3
- group Id
- OG001
- spread
- 10.31
- value
- -9.7
- group Id
- OG002
- spread
- 9.75
- value
- -1.7
- group Id
- OG003
- spread
- 13.72
- value
- -0.3
- title
- PR at Day 2 (n=6,6,6,21)
- categories
- measurements
- group Id
- OG000
- spread
- 6.90
- value
- 5.0
- group Id
- OG001
- spread
- 7.48
- value
- -2.0
- group Id
- OG002
- spread
- 19.83
- value
- -8.7
- group Id
- OG003
- spread
- 5.57
- value
- -1.2
- title
- QRS at Day 2 (n=6,6,6,21)
- categories
- measurements
- group Id
- OG000
- spread
- 27.86
- value
- 2.0
- group Id
- OG001
- spread
- 22.89
- value
- -15.7
- group Id
- OG002
- spread
- 15.90
- value
- -2.0
- group Id
- OG003
- spread
- 20.76
- value
- -10.1
- title
- QT at Day 2 (n=6,6,6,21)
- categories
- measurements
- comment
- no participants with data on this day in this arm
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- no participants with data on this day in this arm
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- no participants with data on this day in this arm
- group Id
- OG002
- spread
- NA
- value
- NA
- group Id
- OG003
- spread
- 24.11
- value
- -11.3
- title
- PR at Day 57 (n=0,0,0,3)
- categories
- measurements
- comment
- no participants with data on this day in this arm
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- no participants with data on this day in this arm
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- no participants with data on this day in this arm
- group Id
- OG002
- spread
- NA
- value
- NA
- group Id
- OG003
- spread
- 5.03
- value
- 1.3
- title
- QRS at Day 57 (n=0,0,0,3)
- categories
- measurements
- comment
- no participants with data on this day in this arm
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- no participants with data on this day in this arm
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- no participants with data on this day in this arm
- group Id
- OG002
- spread
- NA
- value
- NA
- group Id
- OG003
- spread
- 33.61
- value
- 5.3
- title
- QT at Day 57 (n=0,0,0,3)
- categories
- measurements
- comment
- no participants with data on this day in this arm
- group Id
- OG000
- spread
- NA
- value
- NA
- group Id
- OG001
- spread
- 11.82
- value
- -4.5
- group Id
- OG002
- spread
- 17.69
- value
- 3.5
- group Id
- OG003
- spread
- 17.44
- value
- -1.1
- title
- PR at Day 85 (n=0,4,4,11)
- categories
- measurements
- comment
- no participants with data on this day in this arm
- group Id
- OG000
- spread
- NA
- value
- NA
- group Id
- OG001
- spread
- 9.09
- value
- -6.0
- group Id
- OG002
- spread
- 6.73
- value
- -4.0
- group Id
- OG003
- spread
- 4.24
- value
- 0.2
- title
- QRS at Day 85 (n=0,4,4,11)
- categories
- measurements
- comment
- no participants with data on this day in this arm
- group Id
- OG000
- spread
- NA
- value
- NA
- group Id
- OG001
- spread
- 27.90
- value
- -6.0
- group Id
- OG002
- spread
- 33.52
- value
- -3.5
- group Id
- OG003
- spread
- 26.40
- value
- -0.2
- title
- QT at Day 85 (n=0,4,4,11)
- categories
- measurements
- comment
- no participants with data on this day in this arm
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- no participants with data on this day in this arm
- group Id
- OG001
- spread
- NA
- value
- NA
- group Id
- OG002
- spread
- 24.04
- value
- 11.0
- group Id
- OG003
- spread
- 4.62
- value
- 3.3
- title
- PR at Day 113 (n=0,0,2,3)
- categories
- measurements
- comment
- no participants with data on this day in this arm
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- no participants with data on this day in this arm
- group Id
- OG001
- spread
- NA
- value
- NA
- group Id
- OG002
- spread
- 2.83
- value
- 4.0
- group Id
- OG003
- spread
- 6.93
- value
- 6.0
- title
- QRS at Day 113 (n=0,0,2,3)
- categories
- measurements
- comment
- no participants with data on this day in this arm
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- no participants with data on this day in this arm
- group Id
- OG001
- spread
- NA
- value
- NA
- group Id
- OG002
- spread
- 50.91
- value
- 4.0
- group Id
- OG003
- spread
- 28.00
- value
- 6.0
- title
- QT at Day 113 (n=0,0,2,3)
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 21
- units
- Participants
- description
- 12-lead ECGs were performed at screening, baseline, Day 2 and at completion of the dose cycle (Day 85 in first dose cycle). In those participants undergoing re-treatment, ECG was repeated at the completion of the re-treatment. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. PR, QRS and QT interval were measured in milliseconds (msec).
- dispersion Type
- Standard Deviation
- groups
- description
- 0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
- id
- OG000
- title
- 0.3 mg/kg Nivolumab
- description
- 1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
- id
- OG001
- title
- 1 mg/kg Nivolumab
- description
- 3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
- id
- OG002
- title
- 3 mg/kg Nivolumab
- description
- 10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
- id
- OG003
- title
- 10 mg/kg Nivolumab
- param Type
- MEAN
- population Description
- All participants who received at least 1 dose or any partial dose of nivolumab and had available ECG at baseline and on the specified post treatment study day were analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline, Day 2, Day 85, Day 113
- title
- Mean Change From Baseline in Electrocardiogram Parameters PR, QRS and QT in Safety Population
- type
- SECONDARY
- unit Of Measure
- msec
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle