Participant flow

Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267) · Source last updated 2017-06-06

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

groups

1. description

   temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)

   id

   FG000

   title

   Temozolomide

2. description

   dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks

   id

   FG001

   title

   Dacarbazine

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   2. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         22

      type

      Subject's Refusal unrelated to toxicity

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      type

      Death not due to malignancy/toxicity

   4. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         22

      type

      Medical Decision unrelated toxicity/PD

   5. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         13

      type

      Other Reason

   6. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         12

      type

      Ongoing (still on treatment)

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Major Protocol Violation

   8. reasons

      1. group Id

         FG000

         num Subjects

         53

      2. group Id

         FG001

         num Subjects

         9

      type

      Toxicity (Related AE)

   milestones

   1. achievements

      1. comment

         10 subjects in temozolomide group not treated.

         group Id

         FG000

         num Subjects

         429

      2. comment

         9 subjects in dacarbazine group not treated.

         group Id

         FG001

         num Subjects

         430

      type

      STARTED

   2. achievements

      1. comment

         Progressive disease/relapse/death due to progressive disease

         group Id

         FG000

         num Subjects

         334

      2. comment

         Progressive disease/relapse/death due to progressive disease

         group Id

         FG001

         num Subjects

         348

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         95

      2. group Id

         FG001

         num Subjects

         82

      type

      NOT COMPLETED

   title

   Overall Study

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice