NCT02065687 · OUTCOME

Number of Participants With Grade 3 or Higher Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4

Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer · Source last updated 2021-09-30

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: Up to 5 years

What was measured

Toxicities will be assessed by organ or organ system. For each category of toxicity, each patient will be evaluated by the worst grade experienced during the course of therapy. Data will be summarized by frequency and severity according to the regimen administered. The number of patients with a grade three or greater adverse event will be reported (by system organ class).

Analysis population: All patients.

Groups in this outcome

Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)

Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Arm II (Paclitaxel, Carboplatin, Placebo)

Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days 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 (Paclitaxel, Carboplatin, Metformin Hydrochloride)	234
Arm II (Paclitaxel, Carboplatin, Placebo)	235

Reported measurements

Blood and lymphatic system disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	23	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	17	Not reported	Not reported	Not reported	Not reported

Cardiac disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	2	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	2	Not reported	Not reported	Not reported	Not reported

Ear and labyrinth disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	0	Not reported	Not reported	Not reported	Not reported

Endocrine disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	0	Not reported	Not reported	Not reported	Not reported

Eye disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	0	Not reported	Not reported	Not reported	Not reported

Gastrointestinal disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	17	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	10	Not reported	Not reported	Not reported	Not reported

General disorders administration site conditions

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	5	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	6	Not reported	Not reported	Not reported	Not reported

Immune system disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	1	Not reported	Not reported	Not reported	Not reported

Infections and infestations

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	14	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	10	Not reported	Not reported	Not reported	Not reported

Injury, poisoning and procedural complications

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	2	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	6	Not reported	Not reported	Not reported	Not reported

Investigations

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	38	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	28	Not reported	Not reported	Not reported	Not reported

Metabolism and Nutrition Disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	8	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	18	Not reported	Not reported	Not reported	Not reported

Musculoskeletal and connective tissue disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	3	Not reported	Not reported	Not reported	Not reported

Neoplasms benign, malignant and unspecified

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	0	Not reported	Not reported	Not reported	Not reported

Nervous system disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	8	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	9	Not reported	Not reported	Not reported	Not reported

Psychiatric disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	2	Not reported	Not reported	Not reported	Not reported

Renal and urinary disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	5	Not reported	Not reported	Not reported	Not reported

Reproductive system and breast disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	0	Not reported	Not reported	Not reported	Not reported

Respiratory, thoracic and mediastinal disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	7	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	4	Not reported	Not reported	Not reported	Not reported

Skin and subcutaneous tissue disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	2	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	1	Not reported	Not reported	Not reported	Not reported

Vascular disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	10	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	18	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
23
group Id
OG001
value
17
title
Blood and lymphatic system disorders
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
title
Cardiac disorders
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Ear and labyrinth disorders
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Endocrine disorders
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Eye disorders
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
10
title
Gastrointestinal disorders
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
6
title
General disorders administration site conditions
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Immune system disorders
categories
measurements
group Id
OG000
value
14
group Id
OG001
value
10
title
Infections and infestations
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
6
title
Injury, poisoning and procedural complications
categories
measurements
group Id
OG000
value
38
group Id
OG001
value
28
title
Investigations
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
18
title
Metabolism and Nutrition Disorders

denoms

counts
group Id
OG000
value
234
group Id
OG001
value
235
units
Participants

description

groups

description
Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
id
OG000
title
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)
description
Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
id
OG001
title
Arm II (Paclitaxel, Carboplatin, Placebo)

param Type

COUNT_OF_PARTICIPANTS

population Description

All patients.

reporting Status

POSTED

time Frame

Up to 5 years

title

Number of Participants With Grade 3 or Higher Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice