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NCT01259856 · OUTCOME

Number of Participants With Grade 3 and Grade 4 Hematological and Non-hematological Events

Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) · Source last updated 2019-04-30

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
4 years

What was measured

Number of Participants with Grade 3 and Grade 4 Hematological and Non-hematological Events using the Common Terminology Criteria for Adverse Events (CTCAE) 4.0 to assess the toxicity, safety and tolerability of therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea).

Groups in this outcome

PEGASYS

The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months. Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.

Hydroxyurea

Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment. Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.

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

Analysis denominator · Participants

GroupSource count
PEGASYS82
Hydroxyurea86

Reported measurements

Grade 3 Hematological event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGASYS3Not reportedNot reportedNot reportedNot reported
Hydroxyurea2Not reportedNot reportedNot reportedNot reported
Grade 4 Hematological event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGASYS0Not reportedNot reportedNot reportedNot reported
Hydroxyurea0Not reportedNot reportedNot reportedNot reported
Grade 3 Non-hematological event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGASYS27Not reportedNot reportedNot reportedNot reported
Hydroxyurea14Not reportedNot reportedNot reportedNot reported
Grade 4 Non-hematological event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGASYS2Not reportedNot reportedNot reportedNot reported
Hydroxyurea3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
    title
    Grade 3 Hematological event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Grade 4 Hematological event
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        14
    title
    Grade 3 Non-hematological event
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
    title
    Grade 4 Non-hematological event
denoms
  1. counts
    1. group Id
      OG000
      value
      82
    2. group Id
      OG001
      value
      86
    units
    Participants
description
Number of Participants with Grade 3 and Grade 4 Hematological and Non-hematological Events using the Common Terminology Criteria for Adverse Events (CTCAE) 4.0 to assess the toxicity, safety and tolerability of therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea).
groups
  1. description
    The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months. Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
    id
    OG000
    title
    PEGASYS
  2. description
    Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment. Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
    id
    OG001
    title
    Hydroxyurea
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
4 years
title
Number of Participants With Grade 3 and Grade 4 Hematological and Non-hematological Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice