NCT00351468 · OUTCOME

Overall Summary of On-Therapy Adverse Events (Safety Population)

EXTEND (Eltrombopag Extended Dosing Study) · Source last updated 2017-04-17

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

Measure: NUMBER
Unit: Participants
Interval / dispersion: Not reported
Time frame: Start date was the first dose of investigational product and up to the day after the last dose . Post-therapy: start date was more than 1 day after the last dose and up to 30 days after last dose of investigational product up to week 364

What was measured

All safety evaluation findings considered to be adverse events are reported in the Adverse Event section.

Groups in this outcome

Eltrombopag

Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.

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
Eltrombopag	302

Reported measurements

Any adverse event

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag	277	Not reported	Not reported	Not reported	Not reported

Any serious adverse event

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag	96	Not reported	Not reported	Not reported	Not reported

Adverse events related to study medication

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag	133	Not reported	Not reported	Not reported	Not reported

Adverse events leading to withdrawal

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag	41	Not reported	Not reported	Not reported	Not reported

Serious adverse events leading withdrawal

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag	28	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
277
title
Any adverse event
categories
measurements
group Id
OG000
value
96
title
Any serious adverse event
categories
measurements
group Id
OG000
value
133
title
Adverse events related to study medication
categories
measurements
group Id
OG000
value
41
title
Adverse events leading to withdrawal
categories
measurements
group Id
OG000
value
28
title
Serious adverse events leading withdrawal

denoms

counts
group Id
OG000
value
302
units
Participants

description

All safety evaluation findings considered to be adverse events are reported in the Adverse Event section.

groups

description
Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
id
OG000
title
Eltrombopag

param Type

NUMBER

reporting Status

POSTED

time Frame

Start date was the first dose of investigational product and up to the day after the last dose . Post-therapy: start date was more than 1 day after the last dose and up to 30 days after last dose of investigational product up to week 364

title

Overall Summary of On-Therapy Adverse Events (Safety Population)

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice