Participant flow

Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma · Source last updated 2019-09-09

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

groups

1. description

   Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle

   id

   FG000

   title

   Docetaxel

2. description

   Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

   id

   FG001

   title

   Docetaxel + Ramucirumab DP

3. description

   Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

   id

   FG002

   title

   Docetaxel + Icrucumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Lost to Follow-up

   2. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         3

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Never Treated "Death"

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Never Treated "PD"

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Protocol Violation

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         49

      2. group Id

         FG001

         num Subjects

         49

      3. group Id

         FG002

         num Subjects

         50

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         45

      2. group Id

         FG001

         num Subjects

         46

      3. group Id

         FG002

         num Subjects

         49

      type

      Received at Least 1 Dose of Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         41

      2. group Id

         FG001

         num Subjects

         45

      3. group Id

         FG002

         num Subjects

         46

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         4

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants who died or discontinued treatment due to progressive disease (PD) were considered completers at the end of study. 8 participants were included in the "never treated" group due to death, PD, withdrawal, physician decision or protocol violation.

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

Preserved source evidence · Not medical advice