Participant flow

A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200) · Source last updated 2023-07-10

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

groups

1. description

   Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.

   id

   FG000

   title

   Avelumab

2. description

   Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.

   id

   FG001

   title

   Avelumab + PLD

3. description

   PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.

   id

   FG002

   title

   Pegylated Liposomal Doxorubicin (PLD)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         30

      3. group Id

         FG002

         num Subjects

         20

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         5

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         11

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         3

      type

      Other

   5. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         31

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         18

      3. group Id

         FG002

         num Subjects

         24

      type

      Global Deterioration of Health Status

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      type

      No Longer Meets Eligibility Criteria

   8. reasons

      1. group Id

         FG000

         num Subjects

         137

      2. group Id

         FG001

         num Subjects

         125

      3. group Id

         FG002

         num Subjects

         94

      type

      Progressive Disease

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Non-Compliance With Study Drug

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         188

      2. group Id

         FG001

         num Subjects

         188

      3. group Id

         FG002

         num Subjects

         190

      comment

      This table included all randomized participants.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         187

      2. group Id

         FG001

         num Subjects

         182

      3. group Id

         FG002

         num Subjects

         177

      comment

      Participants received at least 1 dose of study drug.

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      comment

      Participants were considered completed when at least one drug of the combination is completed.

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         188

      2. group Id

         FG001

         num Subjects

         188

      3. group Id

         FG002

         num Subjects

         190

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Data reported based on last participant last visit (LPLV) date (12 July 2022).

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Preserved source evidence · Not medical advice