HD 1991 - Hodgkin's disease - analysis details:
endpoints, steering files and strata
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Contents List
HD
1991 run-time diktats
-
Working definition of 'probable Hodgkin's
disease deaths'
-
Includes deaths within 365 days of remission
failure (or deaths within 456 days of diagnosis if date of remission failure
is missing); deaths within 90 days of relapse; and deaths within 90 days
of diagnosis where no primary treatment outcome has been stated.
-
'Remission failure'
-
Interpretation depends on endpoint (N.B:
formerly, treated as 'relapse on day 1' at run-time).
-
Run-time estimation of unknown randomisation
date
-
Set randomisation date to the earliest known
date of:
-
Today
-
Cutoff date (if any)
-
LFU/death date
-
Recurrence date
-
Date of initial treatment/diagnosis (N.B:
formerly not used)
-
Run-time estimation of unknown endpoint/censoring
date
-
Set endpoint/censoring date to the latest
known date of:
-
Randomisation date
-
Recurrence 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 detailed-age-stratified analysis)
-
Run-time definition of 'probable Hodgkin's
disease deaths'
-
Excludes all deaths with 'unknown cause'.
List
of HD 1991 endpoints
|
Endpoint |
Mnemonic |
Trial inclusion criteria |
| 1 |
MORTALITY |
DD |
|
| 2 |
FAILURE-FREE SURVIVAL |
RL |
recurrence |
| 3 |
HODGKIN'S DISEASE MORTALITY (not used) |
DDHD |
death cause |
| 4 |
MORTALITY FROM NON-HODGKIN'S-DISEASE CAUSES |
NONHD |
death cause |
| 5 |
MORTALITY FROM IATROGENIC CAUSES WITHOUT
RELAPSE |
IATRO |
death cause |
| 6 |
MORTALITY FROM SOLID NEOPLASM WITHOUT
RELAPSE |
DDPP |
death cause |
| 7 |
LEUKAEMIA MORTALITY WITHOUT RELAPSE |
DDLEUK |
death cause |
| 8 |
CARDIOVASCULAR MORTALITY WITHOUT RELAPSE |
CVASC |
death cause |
| 9 |
TIME TO FAILURE |
RLF |
recurrence, death cause |
| 10 |
MORTALITY FROM NON-HODGKIN'S-DISEASE CAUSES
WITHOUT RELAPSE |
NONHDRL |
death cause |
| 11 |
MORTALITY FROM NON-HODGKIN'S LYMPHOMA
WITHOUT RELAPSE |
NHL |
death cause |
| 12 |
MORTALITY FROM PULMONARY CAUSES WITHOUT
RELAPSE |
DDLUNG |
death cause |
| 13 |
MORTALITY FROM INFECTIVE CAUSES WITHOUT
RELAPSE |
INFECT |
death cause |
| 14 |
MORTALITY FROM "HODGKIN'S DISEASE" =
(DD - NONHDUKRL) |
DDPOSTREC |
|
| 15 |
MORTALITY FROM NON-HODGKIN'S-DISEASE OR
UNKNOWN CAUSES WITHOUT RELAPSE |
NONHDUKRL |
|
| 16 |
MORTALITY FROM UNKNOWN CAUSES WITHOUT
RELAPSE |
DDUKRL |
|
| 17 |
MORTALITY FROM EXTRANEOUS CAUSES WITHOUT
RELAPSE |
EXTRA |
death cause |
| 18 |
MORTALITY FROM UNSTATED CAUSES WITHOUT
RELAPSE |
DC0NRL |
death cause |
| 19 |
MORTALITY FROM OTHER SPECIFIED CAUSES
WITHOUT RELAPSE |
DC9NRL |
death cause |
| 20 |
MORTALITY FROM UNSPECIFIED NON-HODGKIN'S-DISEASE
CAUSES WITHOUT RELAPSE |
DC10NRL |
death cause |
| 21 |
MORTALITY FROM UNASCERTAINABLE CAUSES
WITHOUT RELAPSE |
DC12NRL |
death cause |
| 22 |
MORTALITY OMITTING NON-HODGKIN'S-DISEASE
DEATHS WITHOUT RELAPSE = (DD - NONHDRL) |
DDPOSTRECB |
death cause |
HD
1991 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. In addition to the Diktats concerning
missing dates etc, the following precepts are applied globally at
run-time:
-
In addition to cases with 'recurrence' flags
set, a recurrence is taken to be present if a date of first recurrence
is present.
CVASC: CARDIOVASCULAR MORTALITY WITHOUT RELAPSE
An event is taken to have occurred if:
-
remission failure is not reported and recurrence
has not occurred and death has occurred and the cause of death is 'cardiovascular'.
The event date is taken as the date died.
If an event is not taken to have occurred,
the case is censored at the earliest of the date died or last traced, the
date of first recurrence (if non-null) and (if remission failure is reported)
the randomisation date.
DC0NRL: MORTALITY FROM CODE-0 CAUSES WITHOUT
RELAPSE
An event is taken to have occurred if:
-
remission failure is not reported and recurrence
has not occurred and death has occurred without a cause stated.
The event date is taken as the date died.
If an event is not taken to have occurred,
the case is censored at the earliest of the date died or last traced, the
date of first recurrence (if non-null) and (if remission failure is reported)
the randomisation date.
DC9NRL: MORTALITY FROM CODE-9 CAUSES WITHOUT
RELAPSE
An event is taken to have occurred if:
-
remission failure is not reported and recurrence
has not occurred and death has occurred with cause code '9'.
The event date is taken as the date died.
If an event is not taken to have occurred,
the case is censored at the earliest of the date died or last traced, the
date of first recurrence (if non-null) and (if remission failure is reported)
the randomisation date.
DC10NRL: MORTALITY FROM CODE-10 CAUSES WITHOUT
RELAPSE
An event is taken to have occurred if:
-
remission failure is not reported and recurrence
has not occurred and death has occurred with cause code '10'.
The event date is taken as the date died.
If an event is not taken to have occurred,
the case is censored at the earliest of the date died or last traced, the
date of first recurrence (if non-null) and (if remission failure is reported)
the randomisation date.
DC12NRL: MORTALITY FROM CODE-12 CAUSES WITHOUT
RELAPSE
An event is taken to have occurred if:
-
remission failure is not reported and recurrence
has not occurred and death has occurred with cause code '12'.
The event date is taken as the date died.
If an event is not taken to have occurred,
the case is censored at the earliest of the date died or last traced, the
date of first recurrence (if non-null) and (if remission failure is reported)
the randomisation date.
DD: MORTALITY
An event is taken to have occurred if:
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.
DDHD: HODGKIN'S DISEASE MORTALITY
An event is taken to have occurred if:
-
death has occurred and the cause of death
is 'Hodgkin's disease'.
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.
EXTRA: MORTALITY FROM EXTRANEOUS CAUSES WITHOUT
RELAPSE
An event is taken to have occurred if:
-
remission failure is not reported and recurrence
has not occurred and death has occurred and the cause of death is 'extraneous'.
The event date is taken as the date died.
If an event is not taken to have occurred,
the case is censored at the earliest of the date died or last traced, the
date of first recurrence (if non-null) and (if remission failure is reported)
the randomisation date.
NONHD: MORTALITY FROM NON-HODGKIN'S-DISEASE
CAUSES
An event is taken to have occurred if:
-
death has occurred and the cause of death
is 'unknown', not stated or anything except 'Hodgkin's disease'.
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.
DDPOSTREC: MORTALITY FROM "HODGKIN'S DISEASE"
(formerly MORTALITY OMITTING NON-HODGKIN'S-DISEASE AND UNKNOWN-CAUSE DEATHS
WITHOUT RELAPSE)
This endpoint is formed by subtraction of
the annual events, (O - E) and variance of NONHDUKRL from DD, q.v.
DDPOSTRECB: MORTALITY OMITTING NON-HODGKIN'S-DISEASE
DEATHS WITHOUT RELAPSE
This endpoint is formed by subtraction of
the annual events, (O - E) and variance of NONHDRL from DD, q.v.
DDUKRL: MORTALITY FROM UNKNOWN CAUSES WITHOUT
RELAPSE
An event is taken to have occurred if:
-
remission failure is not reported and recurrence
has not occurred and death has occurred; and
-
the cause of death is 'unknown' or is not
stated.
The event date is taken as the date died.
If an event is not taken to have occurred,
the case is censored at the earliest of the date died or last traced, the
date of first recurrence (if non-null) and (if remission failure is reported)
the randomisation date.
IATRO: MORTALITY FROM IATROGENIC CAUSES WITHOUT
RELAPSE
An event is taken to have occurred if:
-
remission failure is not reported and recurrence
has not occurred and death has occurred and the cause of death is 'iatrogenic'.
The event date is taken as the date died.
If an event is not taken to have occurred,
the case is censored at the earliest of the date died or last traced, the
date of first recurrence (if non-null) and (if remission failure is reported)
the randomisation date.
INFECT: MORTALITY FROM INFECTIVE CAUSES WITHOUT
RELAPSE
An event is taken to have occurred if:
-
remission failure is not reported and recurrence
has not occurred and death has occurred and the cause of death is 'infective'.
The event date is taken as the date died.
If an event is not taken to have occurred,
the case is censored at the earliest of the date died or last traced, the
date of first recurrence (if non-null) and (if remission failure is reported)
the randomisation date.
LEUK: LEUKAEMIA MORTALITY WITHOUT RELAPSE
An event is taken to have occurred if:
-
remission failure is not reported and recurrence
has not occurred and death has occurred and the cause of death is 'leukaemia'.
The event date is taken as the date died.
If an event is not taken to have occurred,
the case is censored at the earliest of the date died or last traced, the
date of first recurrence (if non-null) and (if remission failure is reported)
the randomisation date.
LUNG: MORTALITY FROM PULMONARY CAUSES WITHOUT
RELAPSE
An event is taken to have occurred if:
-
remission failure is not reported and recurrence
has not occurred and death has occurred and the cause of death is 'pulmonary'.
The event date is taken as the date died.
If an event is not taken to have occurred,
the case is censored at the earliest of the date died or last traced, the
date of first recurrence (if non-null) and (if remission failure is reported)
the randomisation date.
NHL: MORTALITY FROM NON-HODGKIN'S LYMPHOMA
WITHOUT RELAPSE
An event is taken to have occurred if:
-
remission failure is not reported and recurrence
has not occurred and death has occurred and the cause of death is 'non-Hodgkin's
lymphoma'.
The event date is taken as the date died.
If an event is not taken to have occurred,
the case is censored at the earliest of the date died or last traced, the
date of first recurrence (if non-null) and (if remission failure is reported)
the randomisation date.
NONHDRL: MORTALITY FROM NON-HODGKIN'S-DISEASE
CAUSES WITHOUT RELAPSE
An event is taken to have occurred if:
-
remission failure is not reported and recurrence
has not occurred and death has occurred and the cause of death is stated
as anything except 'Hodgkin's disease' or 'unknown'.
The event date is taken as the date died.
If an event is not taken to have occurred,
the case is censored at the earliest of the date died or last traced, the
date of first recurrence (if non-null) and (if remission failure is reported)
the randomisation date.
NONHDUKRL: MORTALITY FROM NON-HODGKIN'S-DISEASE
OR UNKNOWN CAUSES WITHOUT RELAPSE
An event is taken to have occurred if:
-
remission failure is not reported and recurrence
has not occurred and death has occurred; and
-
the cause of death is anything except 'Hodgkin's
disease' or is not stated.
The event date is taken as the date died.
If an event is not taken to have occurred,
the case is censored at the earliest of the date died or last traced, the
date of first recurrence (if non-null) and (if remission failure is reported)
the randomisation date.
PP: MORTALITY FROM SOLID NEOPLASM WITHOUT
RELAPSE
An event is taken to have occurred if:
-
remission failure is not reported and recurrence
has not occurred and death has occurred and the cause of death is 'solid
neoplasm'.
The event date is taken as the date died.
If an event is not taken to have occurred,
the case is censored at the earliest of the date died or last traced, the
date of first recurrence (if non-null) and (if remission failure is reported)
the randomisation date.
RL: FAILURE-FREE SURVIVAL
An event is taken to have occurred if:
-
death has occurred or recurrence has occurred.
The event date is taken as the date of first
recurrence if recurrence has occurred, or else the date died.
If an event is not taken to have occurred,
the case is censored at the date last traced.
RLF: TIME TO FAILURE (formerly RELAPSE OR
HODGKIN'S DISEASE DEATH AS FIRST EVENT)
An event is taken to have occurred if:
-
death has occurred and the cause of death
is 'Hodgkin's disease'; or
-
recurrence has occurred.
The event date is taken as the date of first
recurrence if recurrence has occurred, or else the date died.
If an event is not taken to have occurred,
the case is censored at the date died or last traced.
List
of HD 1991 strata
|
Stratification |
Mnemonic |
Structure |
| 0 |
Unstratified |
0 |
|
| 1 |
Entry Age |
30 |
|
Stratum |
Abbreviation |
| 1 |
Entry age less than 30 |
Age < 30 |
| 2 |
Entry age 30 or more |
Age 30+/unknown |
|
| 2 |
Entry Age |
A |
|
Stratum |
Abbreviation |
| 1 |
Entry age less than 10 |
Age < 10 |
| 2 |
Entry age 10 - 19 |
Age 10 - 19 |
| 3 |
Entry age 20 - 29 |
Age 20 - 29 |
| 4 |
Entry age 30 - 39 |
Age 30 - 39 |
| 5 |
Entry age 40 - 49 |
Age 40 - 49 |
| 6 |
Entry age 50 - 59 |
Age 50 - 59 |
| 7 |
Entry age 60 or more |
Age 60+ |
| 8 |
Entry age unknown |
Age unknown |
|
| 3 |
Disease Stage |
HS |
|
Stratum |
Abbreviation |
| 1 |
Stage I |
Stage I |
| 2 |
Stage II |
Stage II |
| 3 |
Stage III |
Stage III |
| 4 |
Stage IV |
Stage IV |
| 5 |
Stage unknown |
Stage unknown |
|
| 4 |
Sys. Symptoms |
HY |
|
Stratum |
Abbreviation |
| 1 |
Symptoms absent |
Absent |
| 2 |
Symptoms present |
Present |
| 3 |
Symptoms unknown |
Symptoms unknown |
|
| 5 |
Gender |
G |
|
Stratum |
Abbreviation |
| 1 |
Males |
Males |
| 2 |
Females |
Females |
| 3 |
Genders unknown |
Gender unknown |
|
| 6 |
Entry Age |
A2 |
|
Stratum |
Abbreviation |
| 1 |
Entry age less than 20 |
Age < 20 |
| 2 |
Entry age 20 - 29 |
Age 20 - 29 |
| 3 |
Entry age 30 - 39 |
Age 30 - 39 |
| 4 |
Entry age 40 - 49 |
Age 40 - 49 |
| 5 |
Entry age 50 or more |
Age 50+ |
| 6 |
Entry age unknown |
Age unknown |
|
| 7 |
Tumour Stage |
S2 |
|
Stratum |
Abbreviation |
| 1 |
Stage IA |
Stage IA |
| 2 |
Stage IB |
Stage IB |
| 3 |
Stage IIA |
Stage IIA |
| 4 |
Stage IIB |
Stage IIB |
| 5 |
Stage IIIA |
Stage IIIA |
| 6 |
Stage IIIB |
Stage IIIB |
| 7 |
Stage IV |
Stage IV |
| 8 |
Stage unknown |
Stage unknown |
|
| 8 |
Laparotomy |
L |
|
Stratum |
Abbreviation |
| 1 |
No laparotomy |
No laparotomy |
| 2 |
Laparotomy |
Laparotomy |
| 3 |
Laparotomy unknown |
Lap. unknown |
|
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[End of document, updated to 3 June 2000]