Participant flow

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.

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

   FG000

   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

   FG001

   title

   Multiple Myeloma

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         13

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         8

      type

      Number of Tecemotide Subjects

   3. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         5

      type

      Number of Non-treatment Subjects

   4. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         8

      type

      Safety Analysis Set

   5. achievements

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         13

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Subjects who participated in the tecemotide (L-BLP25) clinical trials (EMR 63325-005, EMR 63325-006, and EMR 63325-008 served as feeder studies) were considered in this follow-up study after the protocol specific inclusion and exclusion criteria to continue their maintenance treatment. A total of 27 subjects were enrolled in this follow-up study.

recruitment Details

First/last subject (informed consent): January 2012/July 2012. Subjects randomized at 9 sites in Canada and Sweden.

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Preserved source evidence · Not medical advice