Participant flow

Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer · Source last updated 2022-11-07

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

groups

1. description

   Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.

   id

   FG000

   title

   Panitumumab Plus BSC

2. description

   Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.

   id

   FG001

   title

   BSC Alone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         2

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         14

      type

      Disease Progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         4

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         27

      2. group Id

         FG001

         num Subjects

         6

      type

      Other

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Non-compliance

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Ongoing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         231

      2. group Id

         FG001

         num Subjects

         232

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         229

      2. group Id

         FG001

         num Subjects

         0

      type

      Received Study Drug

   3. achievements

      1. comment

         Defined as participants who completed safety follow-up visit or who died.

         group Id

         FG000

         num Subjects

         158

      2. comment

         Defined as participants who completed safety follow-up visit or who died.

         group Id

         FG001

         num Subjects

         206

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         73

      2. group Id

         FG001

         num Subjects

         26

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Participants were enrolled from 16 January 2004 through 16 March 2005. Data are up until the data cutoff of 15 March 2007.

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Preserved source evidence · Not medical advice