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NCT01423760 · BASELINE

Baseline characteristics

Common Safety Follow-up Trial of Tecemotide (L-BLP25) · Source last updated 2016-10-06

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

denoms
  1. counts
    1. group Id
      BG000
      value
      14
    2. group Id
      BG001
      value
      13
    3. group Id
      BG002
      value
      27
    units
    Participants
groups
  1. description
    Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
    id
    BG000
    title
    Non-small Cell Lung Cancer (NSCLC)
  2. description
    Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
    id
    BG001
    title
    Multiple Myeloma
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.98
          value
          67.7
        2. group Id
          BG001
          spread
          9.81
          value
          65.2
        3. group Id
          BG002
          spread
          9.30
          value
          66.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Screening analysis set included all the subjects included in the trial.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      14
    2. group Id
      BG001
      value
      13
    3. group Id
      BG002
      value
      27
    units
    Participants
groups
  1. description
    Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
    id
    BG000
    title
    Non-small Cell Lung Cancer (NSCLC)
  2. description
    Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
    id
    BG001
    title
    Multiple Myeloma
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.98
          value
          67.7
        2. group Id
          BG001
          spread
          9.81
          value
          65.2
        3. group Id
          BG002
          spread
          9.30
          value
          66.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Screening analysis set included all the subjects included in the trial.

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Preserved source evidence · Not medical advice