NCT01168973 · OUTCOME

Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab

A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy · Source last updated 2019-09-25

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

Measure: GEOMETRIC_MEAN
Unit: micrograms per milliliter (mcg/mL)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Prior to infusion and 1 hour following infusion for 4 and 8 (cycles 3 and 5 at 21 days/cycle)

Analysis population: Participants assigned to the ramucirumab and docetaxel arm at randomization, who had evaluable ramucirumab pharmacokinetic (PK) data to calculate Cmax and Cmin.

Groups in this outcome

Ramucirumab and Docetaxel

On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Ramucirumab DP: 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.

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
Ramucirumab and Docetaxel	594

Reported measurements

Cmax at Cycle 3

Values in micrograms per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab and Docetaxel	262	30	Not reported	Not reported	Not reported

Cmin at Cycle 3

Values in micrograms per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab and Docetaxel	28.3	65	Not reported	Not reported	Not reported

Cmax at Cycle 5

Values in micrograms per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab and Docetaxel	237	38	Not reported	Not reported	Not reported

Cmin at Cycle 5

Values in micrograms per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab and Docetaxel	38.4	63	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
30
value
262
title
Cmax at Cycle 3
categories
measurements
group Id
OG000
spread
65
value
28.3
title
Cmin at Cycle 3
categories
measurements
group Id
OG000
spread
38
value
237
title
Cmax at Cycle 5
categories
measurements
group Id
OG000
spread
63
value
38.4
title
Cmin at Cycle 5

denoms

counts
group Id
OG000
value
594
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Ramucirumab DP: 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
id
OG000
title
Ramucirumab and Docetaxel

param Type

GEOMETRIC_MEAN

population Description

Participants assigned to the ramucirumab and docetaxel arm at randomization, who had evaluable ramucirumab pharmacokinetic (PK) data to calculate Cmax and Cmin.

reporting Status

POSTED

time Frame

Prior to infusion and 1 hour following infusion for 4 and 8 (cycles 3 and 5 at 21 days/cycle)

title

Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab

type

SECONDARY

unit Of Measure

micrograms per milliliter (mcg/mL)

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

Preserved source evidence · Not medical advice