Participant flow

Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients · Source last updated 2024-05-21

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

groups

1. description

   Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W

   id

   FG000

   title

   Treatment A

2. description

   Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles

   id

   FG001

   title

   Treatment B

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      type

      Participant request to discontinue study treatment

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         11

      type

      Participant withdrew consent

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      type

      Participant no longer meets study criteria

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Not reported

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         303

      2. group Id

         FG001

         num Subjects

         302

      comment

      Started = Randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         300

      2. group Id

         FG001

         num Subjects

         284

      comment

      Completed = Entering treatment

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         18

      type

      NOT COMPLETED

   title

   Pre-treatment

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         182

      2. group Id

         FG001

         num Subjects

         43

      type

      Disease Progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         60

      2. group Id

         FG001

         num Subjects

         24

      type

      Study Drug Toxicity

   3. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         9

      type

      Adverse Event unrelated to Study Drug

   4. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         10

      type

      Participant request to discontinue Study treatment

   5. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         3

      type

      Participant withdrew consent

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   7. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         2

      type

      Maximum Clinical Benefit

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Poor/Non-compliance

   9. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      type

      Participant no longer meets Study criteria

   10. reasons

       1. group Id

          FG000

          num Subjects

          2

       2. group Id

          FG001

          num Subjects

          0

       type

       Administrative reason by Sponsor

   11. reasons

       1. group Id

          FG000

          num Subjects

          12

       2. group Id

          FG001

          num Subjects

          2

       type

       Other reasons

   12. reasons

       1. group Id

          FG000

          num Subjects

          7

       2. group Id

          FG001

          num Subjects

          0

       type

       Not reported

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         300

      2. group Id

         FG001

         num Subjects

         284

      comment

      Started = Entering treatment

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         189

      comment

      Completed

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         300

      2. group Id

         FG001

         num Subjects

         95

      type

      NOT COMPLETED

   title

   Treatment

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Preserved source evidence · Not medical advice