MMY 2002 - myeloma - data structure and protocols

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MMY 2002 data preparation: brief written protocol

Strict confidentiality of trial results is observed. Information is held in the Clinical Trial Service Unit computers in a form which can be accessed only by known individuals.

All patient records are converted into 'pink form' (2002) format (described below) if not already supplied in it. Results received as tables are converted into sets of synthetic records. The following routine checks (where appropriate) are performed on every compilation:

The total numbers of patients and the distributions of randomisation age, Durie/Salmon stage, haemoglobin, platelet and leucocyte measurements and gender are checked for any significant imbalance between treatment groups. These five distributions are compared as follows. Patients are grouped into three categories according to randomisation age (below 50 years; 50 - 69 years or unknown; 70 years or above) and a chi-squared test is applied to the population of the three categories found in each treatment group. Similarly, three categories are formed for Durie/Salmon stage (I; unknown; II/III), for haemoglobin (< 11g/dl; unknown; 11+g/dl), for platelets (< 150 × 109/l; unknown; 150+ × 109/l), for leucocytes (< 5 × 109/l; unknown; 5+ × 109/l) and for gender (male; unknown; female) and these are tested in the same way as the categories formed for randomisation ages.

If an event such as a relapse is reported at a date later than the quoted last follow-up date, the last follow-up date is automatically changed to the later date. The completeness of follow-up is then calculated for the end of each calendar year. The distributions of randomisation dates, randomisation ages and time elapsed since last follow-up are checked for any significant imbalance between treatment groups in two ways as follows. Firstly, a t-test is applied to the difference between the mean value of each distribution for patients in each group with the corresponding mean for patients in the remainder. Secondly, an F-ratio is calculated for each distribution by comparing the variance between the groups with the variance within the groups. The distribution of time elapsed since last follow-up is also checked in these two ways for any significant imbalance between those patients with and those patients without a recorded relapse. Finally, the distribution of time elapsed since last follow-up is checked in the same two ways for any significant imbalance between patients in two categories of Durie/Salmon stage (I; II/III), two categories of haemoglobin measurement (< 11g/dl; 11+g/dl), two categories of platelet measurement (< 150 × 109/l; 150+ × 109/l), two categories of leucocyte measurement (< 5 × 109/l; 5+ × 109/l) and the two genders.

Where patient serial numbers form an obvious sequence it is checked for missing numbers.

A tabulated breakdown of variables is produced for each trial, together (where relevant) with lists of patents in 'problematical' categories such as those with lapsed follow-up, uncertain death cause or second malignancy site. Graphs of accrual date and the proportion of living patients still on follow-up as a function of time from randomisation by treatment allocation are also produced, together with Kaplan-Meier life-table curves. Before trial data are finally incorporated into the overview, the analyses described above are sent to the participating trialist(s) for checking and approval.

Contact

Please address inquiries concerning data preparation and checking to:

Specification of MMY 2002 'pink form' format

Item Description FORTRAN Columns Details Abbreviation
0  Trial/stratum identifying code  I6  1 - 6  Trial 
1  Patient identifier (or sequence number)  A12 8 - 19  Patient Identifier
2  Gender I1  21
Value Description Abbreviation
1  Male Male 
2  Female Fema 
 		 Gend
3  Randomisation age I2  23 - 24  years Age
4  Date of birth I8  26 - 33 DDMMYYYY  
5 Date of diagnosis I8 35 - 42 DDMMYYYY Diagnos Date
6  Date of randomisation I8  44 - 51  DDMMYYYY Random. 
7  Treatment group allocated (as on master list) I1  53  Group 
8 Response I1 55
Value Description Abbreviation
1 Complete Complet
2  Partial Partial
3  None None
4 Not available N.Avail
5 Minimal Minimal
6 Death on induction Death
7 Progression Progres
 		 Respon.
9 Date of response I8  57 - 64 DDMMYYYY Respon. Date
10 Plateau phase? I1 66
Value Description Abbreviation
1  Yes Yes
2  No No
Plateau
11 Date of plateau phase I8  68 - 75 DDMMYYYY Plateau Date
12 Relapse I1 77
Value Description Abbreviation
1  Yes Yes
2  No No
Relapse
13 Date of relapse I8 79 - 86 DDMMYYYY  Relapse Date
14 Survival status I1 88
Value Description Abbreviation
1  Alive Alive
2  Dead Dead
3 Lost Lost
 		 Status
15 Date of last follow-up I8 90 - 97 DDMMYYYY  Status Date
16 Cause of death I2 99 - 100
Value Description Abbreviation
1  Progressive disease  Progr Myel. 
2  Related to myeloma  Myel-Reltd 
3  Unrelated to myeloma  Non-Myel. 
Death Cause
17 Durie/Salmon stage I1  102
Value Description Abbreviation
1  Stage I I
2  Stage II II
3  Stage III III
4 Stage I-II 1-2
 		 D/S
18 Haemoglobin g/dl I3 (##·#) 104 - 106
Value Description Abbreviation
-1 < 9 g/dl < 9 
-2  9 - 10·9 g/dl 9-11 
-3  11 - 11·9 g/dl 11-12
-4 12+ g/dl 12+
-5 <= 6·2 g/dl <6·2
-6 > 6·2 g/dl >6·2
-13 0 g/dl 0·0
 		 Hbg/l
19 Platelets × 109/l I4  108 - 111
Value Description Abbreviation
-1  < 250 × 109/l <250 
-2  250 - 499 × 109/l ~375
-3  500 - 749 × 109/l ~625
-4 750+ × 109/l 750+
-5 <= 120 × 109/l <121
-6 > 120 × 109/l 121+
-13 0 × 109/l 0
 		 Platelets
20 Leucocytes × 109/l I4 (###·#) 113 - 116
Value Description Abbreviation
-1  < 25 × 109/l < 25 
-2  25 - 49 × 109/l 25-49 
-3  50 - 74 × 109/l 50-74
-4 75+ × 109/l 75+
-13 0 × 109/l 0·0
 		 Leucocyte
21  ß2-microglobulin mg/l I3 (##·#) 118 - 120
Value Description Abbreviation
-1  < 10 mg/l  < 10 
-2  10 - 24 mg/l 10-24
-3  25 - 49 mg/l 25-49
-4 50+ mg/l 50+
-5 <= 6 mg/l <6
-6 > 6 mg/l >6
-13 0 mg/l 0·0
 		 ß2-Microgb
22  M band type A2  122 - 123   M Band
23  Serum creatinine I5 (####·#)  125 - 129
Value Description Abbreviation
-1  < 100 < 100
-2  100 - 129 ~ 115
-3  130+ 130+
-5 < 20 < 20
-6 20+ 20+
-7 <= 177 < 177
-8 > 177 > 177
-13 0 0
Ser.Creati
24  Serum creatinine unit I1  131
Value Description Abbreviation
1  µmol/l µmol/l
2 mg/l mg/l
25  Uncorrected serum calcium I5 (###·##)  133 - 137
Value Description Abbreviation
-1  < 2·5 < 2·5
-2  2·5 - 2·9 ~2·75
-3  3+ 3+
-5 <= 2·6 < 2·6
-6 > 2·6 > 2·6
-13 0 0
 		 Ser.Ca 
26  Uncorrected serum calcium unit I1  139
Value Description Abbreviation
1  mmol/l mmol/l
2 mg/l mg/l
 
27  Serum albumin I5 (####·#) 141 - 145
Value Description Abbreviation
-1  < 250 <250 
-2  250 - 499 ~375
-3  500 - 749 ~625
-4 750+ 750+
-13 0 0
Ser.Alb
28  Serum albumin unit I1  147 
Value Description Abbreviation
1  g/l g/l
29  Bone lesions I1 149
Value Description Abbreviation
1  None None
2  Minimal Minimal
3  Multiple osteolytic lesions Multipl
4 Not avaliable N.Avail
5 Yes Yes
 		 BoneLes
30 Performance status I3 151 - 153
Value Description Abbreviation
-13 Grade 0 0
1  Grade 1 1
2 Grade 2 2
3 Grade 3 3
4 Grade 4 4
 		 Perf.S
31 Performance status coding I1 155
Value Description Abbreviation
1  WHO WHO
2 OMS OMS
3 Karnofsky Karn
4 ECOG ECOG
 
32 Plasma labelling index I3 (##·#) 157 - 159
Value Description Abbreviation
-1  < 25 < 25 
-2  25 - 49 25-49
-3  50 - 74 50-74
-4 75+ 75+
-13 0 0
Plasma
33 C-reactive protein g/l I4 (###·#) 161 - 164
Value Description Abbreviation
-1  < 250 g/l  <250 
-2  250 - 499 g/l ~375
-3  500 - 749 g/l ~625
-4 750+ g/l 750+
-13 0 g/l 0
34 Fractures I1 166
Value Description Abbreviation
1  Yes Yes
2  No No
35 Genetic abnormality detected I1 168
Value Description Abbreviation
1  Yes Yes
2  No No
3 Not done N/A
36 Abnormality of chromosome 13 I1 170
Value Description Abbreviation
1  Yes Yes
2  No No
3 Not done N/A
Items 37-42 below are endpoints requested for the bisphosphonates overview only:
37 Vertebral fractures I1 172
Value Description Abbreviation
1  Yes Yes
2  No No
38 Non-vertebral fractures I1 174
Value Description Abbreviation
1  Yes Yes
2  No No
39 Hypercalcaemia I1 176
Value Description Abbreviation
1  Yes Yes
2  No No
40 Pain I1 178
Value Description Abbreviation
1  Yes Yes
2  No No
41 Toxicity I1 180
Value Description Abbreviation
1  Yes Yes
2  No No
42 Renal dysfunction I1 182
Value Description Abbreviation
1  Yes Yes
2  No No
43 Name (if given) and comments  A  184 - end  Extra Info
Missing or unknown items are left blank or set to zero.

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[End of document, updated to 20 August 2002]