Participant flow

ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer · Source last updated 2014-11-05

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

groups

1. description

   Participants received fluoropyrimidine (EITHER 5-fluorouracil \[5-FU\] or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 milligrams per square meter (mg/m\^2), intravenously (IV), on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, orally (PO), twice daily (BID) from the evening of Day 1 through the morning of Day 15.

   id

   FG000

   title

   Fluoropyrimidine/Cisplatin (FP)

2. description

   Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 milligrams per kilogram (mg/kg), IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.

   id

   FG001

   title

   Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         45

      2. group Id

         FG001

         num Subjects

         35

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         200

      2. group Id

         FG001

         num Subjects

         210

      type

      Lack of Efficacy

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Violation of Selection Criteria

   4. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      type

      Protocol Violation

   5. reasons

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         23

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Failure to Return

   7. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         23

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         290

      2. group Id

         FG001

         num Subjects

         294

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         251

      2. group Id

         FG001

         num Subjects

         251

      type

      Entered Follow-Up

   3. achievements

      1. group Id

         FG000

         num Subjects

         199

      2. group Id

         FG001

         num Subjects

         200

      type

      Died in Follow-up

   4. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         10

      type

      Lost to Follow-up

   5. achievements

      1. group Id

         FG000

         num Subjects

         40

      2. group Id

         FG001

         num Subjects

         41

      type

      Alive in Follow-up

   6. achievements

      1. comment

         Summary of withdrawals represents withdrawals from treatment, rather than withdrawals from study.

         group Id

         FG000

         num Subjects

         0

      2. comment

         Summary of withdrawals represents withdrawals from treatment, rather than withdrawals from study.

         group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   7. achievements

      1. group Id

         FG000

         num Subjects

         290

      2. group Id

         FG001

         num Subjects

         294

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice