Participant flow

Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer · Source last updated 2024-09-03

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

groups

1. description

   Participants received 35 milligrams per meter square (mg/m\^2) of TAS-102 tablets orally twice daily (BID) for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.

   id

   FG000

   title

   TAS-102+BSC

2. description

   Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.

   id

   FG001

   title

   Placebo+BSC

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Randomized, but not Treated

   2. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         3

      type

      Ongoing at Date of Cut-Off

   3. reasons

      1. group Id

         FG000

         num Subjects

         33

      2. group Id

         FG001

         num Subjects

         11

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         54

      2. group Id

         FG001

         num Subjects

         35

      type

      Clinical Progression

   5. reasons

      1. group Id

         FG000

         num Subjects

         192

      2. group Id

         FG001

         num Subjects

         110

      type

      Radiological Progression

   6. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         3

      type

      Physician's Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         4

      type

      Withdrawal by Subject

   8. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         2

      type

      Death

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Protocol Deviation

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         337

      2. group Id

         FG001

         num Subjects

         170

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         335

      2. group Id

         FG001

         num Subjects

         168

      comment

      All participants who received at least 1 dose of study treatment.

      type

      As-Treated (AT) Population

   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

         337

      2. group Id

         FG001

         num Subjects

         170

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Overall, 625 participants were screened, of which 118 were screen failures due to inclusion/exclusion criteria not met and 507 were randomized and treated with TAS-102 or placebo along with Best supportive care (BSC) (BSC was given to prevent, control, or relieve complications and side effects with the intention to maximize quality of life (QoL) without a specific antineoplastic regimen).

recruitment Details

The study was conducted at study centers in 17 countries. Participants were involved in the study from 24 February 2016 to 19 December 2019.

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Preserved source evidence · Not medical advice