TriangleNCT00811733 · OUTCOME
AUC(0-tau) and AUC(0-inf) of Ofatumumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- micrograms X hours/milliliters (µg.h/mL)
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7
What was measured
AUC(0-tau) is the area under the drug concentration-time curve over the dosing interval (one week). AUC(0-inf) is the area under the drug concentration-time curve from time zero extrapolated to infinite time. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.
Analysis population: PK Population. Data were provided for the number of participants attending each visit for whom the parameter could be calculated..
Groups in this outcome
300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5
Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks \[Weeks (Wk.) 1 through 4\]) (300 milligrams \[mg\] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5
Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks \[Weeks 1 through 5\]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
| Group | Source count |
|---|---|
| 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 15 |
| 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 21 |
Reported measurements
AUC(0-tau), Course 1 Dose 4, n=13,0
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 21419 | Not reported | 11637 | 39424 | Not reported |
| 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | NA | Not reported | NA | NA | No participants were analyzed at the indicated time point; therefore, the mean and the CI could not be calculated. |
AUC(0-tau), Course 1 Dose 5, n=0,18
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | NA | Not reported | NA | NA | No participants were analyzed at the indicated time point; therefore, the mean and the CI could not be calculated. |
| 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 75526 | Not reported | 56462 | 101028 | Not reported |
AUC(0-inf), Course 1 Dose 4, n=9,0
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 120886 | Not reported | 53956 | 270842 | Not reported |
| 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | NA | Not reported | NA | NA | No participants were analyzed at the indicated time point; therefore, the mean and the CI could not be calculated. |
AUC(0-inf), Course 1 Dose 5, n=0,18
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | NA | Not reported | NA | NA | No participants were analyzed at the indicated time point; therefore, the mean and the CI could not be calculated. |
| 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 392012 | Not reported | 220019 | 698454 | Not reported |
AUC(0-tau), Course 2 Dose 5, n=10,12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 61259 | Not reported | 36684 | 102296 | Not reported |
| 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 106275 | Not reported | 82044 | 137663 | Not reported |
AUC(0-inf), Course 2 Dose 5, n=8,12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 221675 | Not reported | 70622 | 695814 | Not reported |
| 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 507794 | Not reported | 286020 | 901528 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11637
- upper Limit
- 39424
- value
- 21419
- comment
- No participants were analyzed at the indicated time point; therefore, the mean and the CI could not be calculated.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- AUC(0-tau), Course 1 Dose 4, n=13,0
- categories
- measurements
- comment
- No participants were analyzed at the indicated time point; therefore, the mean and the CI could not be calculated.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 56462
- upper Limit
- 101028
- value
- 75526
- title
- AUC(0-tau), Course 1 Dose 5, n=0,18
- categories
- measurements
- group Id
- OG000
- lower Limit
- 53956
- upper Limit
- 270842
- value
- 120886
- comment
- No participants were analyzed at the indicated time point; therefore, the mean and the CI could not be calculated.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- AUC(0-inf), Course 1 Dose 4, n=9,0
- categories
- measurements
- comment
- No participants were analyzed at the indicated time point; therefore, the mean and the CI could not be calculated.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 220019
- upper Limit
- 698454
- value
- 392012
- title
- AUC(0-inf), Course 1 Dose 5, n=0,18
- categories
- measurements
- group Id
- OG000
- lower Limit
- 36684
- upper Limit
- 102296
- value
- 61259
- group Id
- OG001
- lower Limit
- 82044
- upper Limit
- 137663
- value
- 106275
- title
- AUC(0-tau), Course 2 Dose 5, n=10,12
- categories
- measurements
- group Id
- OG000
- lower Limit
- 70622
- upper Limit
- 695814
- value
- 221675
- group Id
- OG001
- lower Limit
- 286020
- upper Limit
- 901528
- value
- 507794
- title
- AUC(0-inf), Course 2 Dose 5, n=8,12
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 21
- units
- Participants
- description
- AUC(0-tau) is the area under the drug concentration-time curve over the dosing interval (one week). AUC(0-inf) is the area under the drug concentration-time curve from time zero extrapolated to infinite time. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks \[Weeks (Wk.) 1 through 4\]) (300 milligrams \[mg\] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
- id
- OG000
- title
- 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5
- description
- Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks \[Weeks 1 through 5\]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
- id
- OG001
- title
- 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5
- param Type
- GEOMETRIC_MEAN
- population Description
- PK Population. Data were provided for the number of participants attending each visit for whom the parameter could be calculated..
- reporting Status
- POSTED
- time Frame
- From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7
- title
- AUC(0-tau) and AUC(0-inf) of Ofatumumab
- type
- SECONDARY
- unit Of Measure
- micrograms X hours/milliliters (µg.h/mL)
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Preserved source evidence · Not medical advice