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NCT01950364 · OUTCOME

Serum Concentration of Total Antibody (TAb)

A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma · Source last updated 2016-05-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose

What was measured

The LLQ for all the observations was 12.5 ng/mL.

Analysis population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.

Groups in this outcome

Brentuximab Vedotin

Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.

Brentuximab Vedotin + Rifampicin

Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin9
Brentuximab Vedotin + Rifampicin9

Reported measurements

Cycle 1, Predose
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab VedotinNANANot reportedNot reportedNone of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
Brentuximab Vedotin + RifampicinNANANot reportedNot reportedNone of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
Cycle 1, 0.5 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin30874.495711904.18494Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin30884.90749956.67036Not reportedNot reportedNot reported
Cycle 1, 4 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin28577.38699365.88746Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin28865.46748192.50406Not reportedNot reportedNot reported
Cycle 1, 72 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin9931.29434973.74692Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin11626.21474396.55604Not reportedNot reportedNot reported
Cycle 1, 336 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin2898.29241831.73997Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin3066.58591017.84204Not reportedNot reportedNot reported
Cycle 2, Predose
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin2055.387110312.91280Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin1363.8319904.27346Not reportedNot reportedNot reported
Cycle 2, 0.5 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin17378.210517543.51968Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin31583.77937742.69918Not reportedNot reportedNot reported
Cycle 3, Predose
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin1361.31471592.89993Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin1517.65061200.68646Not reportedNot reportedNot reported
Cycle 3, 0.5 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin15974.372312467.10368Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin33892.473110595.70675Not reportedNot reportedNot reported
Cycle 3, 4 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin11609.143014719.69968Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin27548.17737219.71925Not reportedNot reportedNot reported
Cycle 3, 72 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin13594.20167492.70742Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin9588.93745665.38218Not reportedNot reportedNot reported
Cycle 3, 336 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin3206.69253000.22116Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin3628.91751802.66091Not reportedNot reportedNot reported
Cycle 3, 480 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin1329.08862024.17213Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin1866.57461326.12113Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
        group Id
        OG001
        spread
        NA
        value
        NA
    title
    Cycle 1, Predose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        11904.18494
        value
        30874.4957
      2. group Id
        OG001
        spread
        9956.67036
        value
        30884.9074
    title
    Cycle 1, 0.5 hour
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        9365.88746
        value
        28577.3869
      2. group Id
        OG001
        spread
        8192.50406
        value
        28865.4674
    title
    Cycle 1, 4 hour
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        4973.74692
        value
        9931.2943
      2. group Id
        OG001
        spread
        4396.55604
        value
        11626.2147
    title
    Cycle 1, 72 hour
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1831.73997
        value
        2898.2924
      2. group Id
        OG001
        spread
        1017.84204
        value
        3066.5859
    title
    Cycle 1, 336 hour
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        10312.91280
        value
        2055.3871
      2. group Id
        OG001
        spread
        904.27346
        value
        1363.8319
    title
    Cycle 2, Predose
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        17543.51968
        value
        17378.2105
      2. group Id
        OG001
        spread
        7742.69918
        value
        31583.7793
    title
    Cycle 2, 0.5 hour
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        1592.89993
        value
        1361.3147
      2. group Id
        OG001
        spread
        1200.68646
        value
        1517.6506
    title
    Cycle 3, Predose
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        12467.10368
        value
        15974.3723
      2. group Id
        OG001
        spread
        10595.70675
        value
        33892.4731
    title
    Cycle 3, 0.5 hour
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        14719.69968
        value
        11609.1430
      2. group Id
        OG001
        spread
        7219.71925
        value
        27548.1773
    title
    Cycle 3, 4 hour
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        7492.70742
        value
        13594.2016
      2. group Id
        OG001
        spread
        5665.38218
        value
        9588.9374
    title
    Cycle 3, 72 hour
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        3000.22116
        value
        3206.6925
      2. group Id
        OG001
        spread
        1802.66091
        value
        3628.9175
    title
    Cycle 3, 336 hour
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      9
    units
    Participants
description
The LLQ for all the observations was 12.5 ng/mL.
dispersion Type
Standard Deviation
groups
  1. description
    Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
    id
    OG000
    title
    Brentuximab Vedotin
  2. description
    Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
    id
    OG001
    title
    Brentuximab Vedotin + Rifampicin
param Type
GEOMETRIC_MEAN
population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
reporting Status
POSTED
time Frame
Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose
title
Serum Concentration of Total Antibody (TAb)
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice