Baseline characteristics

Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients · Source last updated 2024-02-13

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

      79

   2. group Id

      BG001

      value

      1

   3. group Id

      BG002

      value

      80

   units

   Participants

groups

1. description

   Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).

   id

   BG000

   title

   Main Cohort: Single Dose of CTL019

2. description

   Pediatric B-ALL patients who are very high risk at first relapse.

   id

   BG001

   title

   Cohort 1: Single Dose of CTL019

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            5.38

            value

            12

         2. comment

            NA: Standard deviation cannot be calculated for only 1 patient

            group Id

            BG001

            spread

            NA

            value

            4

         3. group Id

            BG002

            spread

            5.42

            value

            11.9

   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

            34

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            34

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            45

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            46

         title

         Male

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

3. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            58

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            59

      title

      White

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            10

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            10

      title

      Asian

   3. categories

      1. measurements

         1. group Id

            BG000

            value

            11

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            11

      title

      Other

   param Type

   NUMBER

   title

   Race/Ethnicity, Customized

   unit Of Measure

   Participants

population Description

Full Analysis Set (FAS): The Full analysis set comprised all patients who received infusion of tisagenlecleucel.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice