NCT01259856 · OUTCOME

Number of Participants With Partial Remission (PR)

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: 12 months

What was measured

Number of participants with Partial Remission after 12 months of therapy assessed by hematologic response rates two strata of patients with high risk polycythemia vera (PV) or high risk essential thrombocythemia (ET). Partial Remission means decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.

Analysis population: there were 82 participants in PEGASYS arm 39 with ET and 43 with PV, 86 in Hydroxyurea arm 42 with ET and 44 with PV

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

Group	Source count
PEGASYS	82
Hydroxyurea	86

Reported measurements

Essential Thrombocythemia

Analysis denominator · Participants

Group	Source count
PEGASYS	39
Hydroxyurea	42

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
PEGASYS	10	Not reported	Not reported	Not reported	Not reported
Hydroxyurea	11	Not reported	Not reported	Not reported	Not reported

Polycythemia Vera

Analysis denominator · Participants

Group	Source count
PEGASYS	43
Hydroxyurea	44

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
PEGASYS	25	Not reported	Not reported	Not reported	Not reported
Hydroxyurea	17	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
10
group Id
OG001
value
11
denoms
counts
group Id
OG000
value
39
group Id
OG001
value
42
units
Participants
title
Essential Thrombocythemia
categories
measurements
group Id
OG000
value
25
group Id
OG001
value
17
denoms
counts
group Id
OG000
value
43
group Id
OG001
value
44
units
Participants
title
Polycythemia Vera

denoms

counts
group Id
OG000
value
82
group Id
OG001
value
86
units
Participants

description

groups

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
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

population Description

there were 82 participants in PEGASYS arm 39 with ET and 43 with PV, 86 in Hydroxyurea arm 42 with ET and 44 with PV

reporting Status

POSTED

time Frame

12 months

title

Number of Participants With Partial Remission (PR)

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice