CLL 1991 - chronic lymphoblastic leukaemia
- data structure and protocols
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Specification
of CLL 1991 'pink form' format
The CLL project was closed down before any
data were entered into GALAXY. This space reserved for possible future
reactivation.
CLL
1991 data form rubric
GUARANTEE OF CONFIDENTIALITY OF DATA
ANY DATA PROVIDED OVERLEAF WILL BE HELD
SECURELY AND IN STRICT CONFIDENCE.
NOTES ON FORMAT OF DATA REQUESTED OVERLEAF
Please accompany these forms by an explanatory
letter about any special coding conventions you have used, plus notes on
any special features of the study(s) to which you wish to draw particular
attention.
As different treatments are often offered
to different groups of patients, e.g. more severe treatments for
stage B and C patients, please give details of all the treatments within
each randomisation group.
Dates (in DAY/MONTH/YEAR format) that are
not (or not yet) known exactly:
either leave DAY blank, and give
(approximate or provisional) month and year;
or leave DAY and MONTH blank, and
just give approximate year.
ESSENTIAL MINIMUM DATA
Patient number
Any convenient convention you wish, in
case any correspondence becomes necessary. (If reporting several trials,
please try to use a numbering system that implicitly specifies both the
trial and the patient).
Rand. group
For non-randomised patients, enter 0.
Trt
Please enter the originally-allocated
treatment, even if it was not given (for patients erroneously entered more
than once, give only the first allocation).
Date entered study & Age at entry
Please describe ALL patients EVER entered,
including
even lost or withdrawn patients.
Gender
Dead/other
1 = known to be dead; 2 = alive or lost,
but alive when last traced.
Date died/last traced
Date of death, or date last known to be
alive, as accurately as possible. (See above note on approximate dates).
Rai stage
0 = 0; 1 = I; 2 = II; 3 = III; 4 = IV.
International stage
OPTIONAL EXTRA DATA (clinical data to be applicable
at time of entry)
Hb
w.b.c.
Platelets
Spleen size
No. lymph node areas
Number of involved areas, which are i)
head and neck; ii) axillae (one or both); iii) groins (one or both, including
superficial femorals).
BM histology
1 = diffuse; 2 = non-diffuse.
Response
1 = complete; 2 = partial; 3 = minimal;
4 = unchanged; 5 = progression.
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[End of document, updated to 1 September
2000]