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NCT01010061 · OUTCOME

Percentage of Participants With Progression Free Survival Events

CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a) · Source last updated 2018-09-14

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)

What was measured

Percentage of Participants with Progression Free Survival Events: disease progression, relapse, or death.

Analysis population: Intent-to-treat population included all randomized participants.

Groups in this outcome

Obinutuzumab + Chlorambucil (GClb)

Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).

Chlorambucil (Clb)

Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Obinutuzumab + Chlorambucil (GClb)238
Chlorambucil (Clb)118

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)72.7Not reportedNot reportedNot reportedNot reported
Chlorambucil (Clb)90.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        72.7
      2. group Id
        OG001
        value
        90.7
denoms
  1. counts
    1. group Id
      OG000
      value
      238
    2. group Id
      OG001
      value
      118
    units
    Participants
description
Percentage of Participants with Progression Free Survival Events: disease progression, relapse, or death.
groups
  1. description
    Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
    id
    OG000
    title
    Obinutuzumab + Chlorambucil (GClb)
  2. description
    Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
    id
    OG001
    title
    Chlorambucil (Clb)
param Type
NUMBER
population Description
Intent-to-treat population included all randomized participants.
reporting Status
POSTED
time Frame
Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
title
Percentage of Participants With Progression Free Survival Events
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice