PC 2000 - prostate cancer - analysis details: endpoints, steering files and strata for each overview

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PC 2000 - prostate cancer

PC 2000 run-time diktats
List of PC 2000 endpoints
PC 2000 endpoint definitions (awaiting re-write)
List of PC 2000 strata

Data structure and protocols for PC 2000

PC 2000 run-time diktats

Run-time estimation of unknown randomisation date

Set randomisation date to the earliest known date of:

Today
Cutoff date (if any)
LFU/death date

Run-time estimation of unknown endpoint/censoring date

Set endpoint/censoring date to:

Randomisation date

Run-time application of cut-off date, where relevant

If the randomisation date is later than the cut-off date, omit the case.
If the endpoint/censoring date is after the cut-off date, censor at the cut-off date instead.

Run-time estimation of unknown entry age (except for the age-stratified analysis)

Unknown: 65

List of PC 2000 endpoints

	Endpoint	Mnemonic	Trial inclusion criteria
1	MORTALITY	DD
2	PROSTATE CANCER MORTALITY	DDPC	death cause
3	MORTALITY FROM NON-PROSTATE-CANCER CAUSES	NONPC	death cause
4	MORTALITY FROM UNKNOWN CAUSES	DDUK
5	MORTALITY FROM IATROGENIC CAUSES	IATRO	death cause
6	MORTALITY FROM SECOND PRIMARY CANCER	DDPP	death cause
7	CARDIOVASCULAR MORTALITY	CVASC	death cause
8	MORTALITY FROM PROSTATE CANCER OR UNKNOWN CAUSES	DDPCUK
9	MORTALITY FROM NON-PROSTATE-CANCER OR UNKNOWN CAUSES	NONPCUK
10	MORTALITY OMITTING DEATHS FROM NON-PROSTATE-CANCER CAUSES = (DD - NONPC)	DDPOSTREC	death cause
11	PROSTATE CANCER MORTALITY (LOGRANK-SUBTRACTED) = (DD - NONPCUK)	DDPOSTRECB	death cause

PC 2000 endpoint definitions (should be read in conjunction with Diktats)

PLEASE NOTE THAT THIS ENTIRE SECTION IS OUT OF DATE AND IS AWAITING A COMPLETE RE-WRITE!!!

Run-time strategy for data errors

Although efforts are made to create and maintain an 'error-free' database, numerous minor logical inconsistencies may persist during correspondence with trialists.

DD: MORTALITY

An event is taken to have occurred if:

death has occurred.

The event date is taken as the date died.

If an event is not taken to have occurred, the case is censored at the date last traced.

List of PC 2000 strata

Stratification

Mnemonic

Structure

Unstratified

Entry Age

	Stratum	Abbreviation
1	Entry age less than 50	Age < 50
2	Entry age 50 or more	Age 50+

Entry Age

	Stratum	Abbreviation
1	Entry age less than 65	Age < 65
2	Entry age 65 - 74	Age 65 - 74
3	Entry age 75 or more	Age 75+
4	Entry age unknown	Age unknown

Disease Stage

	Stratum	Abbreviation
1	M-	M-
2	M+	M+
3	Stage unknown	M?

Tumour Stage

	Stratum	Abbreviation
1	T0	T0
2	T1	T1
3	T2	T2
4	T3	T3
5	T4	T4
6	Stage unknown	Stage unknown

Entry Age and Disease Stage

	Stratum	Abbreviation
1	M0, entry age less than 65	M0 < 65
2	M+, entry age less than 65	M+ < 65
3	Stage unknown, entry age less than 65	M? < 65
4	M0, entry age 65 - 74	M0 65 - 74
5	M+, entry age 65 - 74	M+ 65 - 74
6	Stage unknown, entry age 65 - 74	M? 65 - 74
7	M0, entry age 75 or more	M0 75+
8	M+, entry age 75 or more	M+ 75+
9	Stage unknown, entry age 75 or more	M? 75+
10	M0, entry age unknown	M0 Age ?
11	M+, entry age unknown	M+ Age ?
12	Stage unknown, entry age unknown	M? Age ?

Regrouping 40 of Entry Age and Disease Stage

-1

	Stratum	Abbreviation
1	Stage M0	M0
2	Stage M+	M+
3	Stage unknown	M?

Regrouping 41 of Entry Age and Disease Stage

-2

	Stratum	Abbreviation
1	Entry age less than 65	Age < 65
2	Entry age 65 - 74	Age 65 - 74
3	Entry age 75 or more	Age 75+
4	Entry age unknown	Age unknown

Regrouping 47 of Entry Age and Disease Stage

-3

	Stratum	Abbreviation
1	Stage M0/unknown	M0/?
2	Stage M+	M+

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[End of document, updated to 15 July 2002]