NCT00063999 · OUTCOME

Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection

Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer · Source last updated 2021-10-19

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: Assessed throughout the treatment period and for 30 days after discontinuation of treatment.

What was measured

Maximum grade of physician assessed neurotoxicity and infection

Analysis population: Eligible and treated patients

Groups in this outcome

Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)

Patients receive doxorubicin hydrochloride IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.

Arm II (Paclitaxel, Carboplatin)

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.

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
Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)	640
Arm II (Paclitaxel, Carboplatin)	664

Reported measurements

Grade < 2 Sensory neuropathy

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)	167	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin)	130	Not reported	Not reported	Not reported	Not reported

Grade 2 or Higher Sensory Neuropathy

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)	473	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin)	534	Not reported	Not reported	Not reported	Not reported

Grade <3 infection with Neutrope

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)	25	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin)	29	Not reported	Not reported	Not reported	Not reported

Grade 3 or Higher Infection with Neutropenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)	615	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin)	635	Not reported	Not reported	Not reported	Not reported

Grade <3 infection without Neutropenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)	22	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin)	13	Not reported	Not reported	Not reported	Not reported

Grade 3 or Higher Infection without Neutropenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)	618	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin)	651	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
167
group Id
OG001
value
130
title
Grade < 2 Sensory neuropathy
categories
measurements
group Id
OG000
value
473
group Id
OG001
value
534
title
Grade 2 or Higher Sensory Neuropathy
categories
measurements
group Id
OG000
value
25
group Id
OG001
value
29
title
Grade <3 infection with Neutrope
categories
measurements
group Id
OG000
value
615
group Id
OG001
value
635
title
Grade 3 or Higher Infection with Neutropenia
categories
measurements
group Id
OG000
value
22
group Id
OG001
value
13
title
Grade <3 infection without Neutropenia
categories
measurements
group Id
OG000
value
618
group Id
OG001
value
651
title
Grade 3 or Higher Infection without Neutropenia

denoms

counts
group Id
OG000
value
640
group Id
OG001
value
664
units
Participants

description

Maximum grade of physician assessed neurotoxicity and infection

groups

description
Patients receive doxorubicin hydrochloride IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
id
OG000
title
Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)
description
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
id
OG001
title
Arm II (Paclitaxel, Carboplatin)

param Type

COUNT_OF_PARTICIPANTS

population Description

Eligible and treated patients

reporting Status

POSTED

time Frame

Assessed throughout the treatment period and for 30 days after discontinuation of treatment.

title

Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice