NCT01968213 · OUTCOME

Individual Model Parameter Estimates of Rucaparib and Covariates Identification

Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3) · Source last updated 2023-06-09

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

Measure: GEOMETRIC_MEAN
Unit: ng/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Study data collection occurred over approximately 7 months.

What was measured

Concentration summary statistics

Analysis population: All patients who are treated with rucaparib with at least one pharmacokinetic (PK) measurement

Groups in this outcome

Rucaparib 600 mg Tablets

Taken orally twice daily (continuous 28 day treatment cycles)

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
Rucaparib 600 mg Tablets	295

Reported measurements

Cycle 2 Day 1

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Rucaparib 600 mg Tablets	1128	95.42	Not reported	Not reported	Not reported

Cycle 4 Day 1

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Rucaparib 600 mg Tablets	1136	86.19	Not reported	Not reported	Not reported

Cycle 7 Day 1

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Rucaparib 600 mg Tablets	1165	78.53	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
95.42
value
1128
title
Cycle 2 Day 1
categories
measurements
group Id
OG000
spread
86.19
value
1136
title
Cycle 4 Day 1
categories
measurements
group Id
OG000
spread
78.53
value
1165
title
Cycle 7 Day 1

denoms

counts
group Id
OG000
value
295
units
Participants

description

Concentration summary statistics

dispersion Type

Geometric Coefficient of Variation

groups

description
Taken orally twice daily (continuous 28 day treatment cycles)
id
OG000
title
Rucaparib 600 mg Tablets

param Type

GEOMETRIC_MEAN

population Description

All patients who are treated with rucaparib with at least one pharmacokinetic (PK) measurement

reporting Status

POSTED

time Frame

Study data collection occurred over approximately 7 months.

title

Individual Model Parameter Estimates of Rucaparib and Covariates Identification

type

SECONDARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice