Participant flow

The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis · Source last updated 2023-11-14

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

groups

1. description

   NEOD001, 24 mg/kg IV every 28 days on top of standard of care until completion of 156 primary endpoints

   id

   FG000

   title

   NEOD001 (24 mg/kg) + Standard of Care

2. description

   Placebo, 0.9% Saline IV every 28 days on top of standard of care until completion of 156 primary endpoints

   id

   FG001

   title

   Placebo + Standard of Care

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         6

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         6

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         6

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         36

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         81

      2. group Id

         FG001

         num Subjects

         74

      type

      Study Terminated by Sponsor

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Patient transferred to hospice

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Subject missed three consecutive treatment visits

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Patient progression and institution of a new therapy

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Disease Progression

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         130

      2. group Id

         FG001

         num Subjects

         130

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         130

      2. group Id

         FG001

         num Subjects

         130

      type

      Informed Consent Obtained

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         130

      2. group Id

         FG001

         num Subjects

         130

      type

      NOT COMPLETED

   title

   Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice