Data structure and protocols: specific information about each overview

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MMY 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 the myeloma data format (2002 overview) (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, sex and stage(eg: Durie-Salmon stage)are checked for any significant imbalance between treatment groups. These five distributions are compared as follows. Patients are grouped into four categories according to randomisation age (below 50 years;  50-59 years; 60-69 years; above 70 years) and a chi-squared test is applied to the population of the four categories found in each treatment group. Similarly, two categories are formed for sex status (male; female).

If an event such as the recurrence of disease 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 recurrence of disease. 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 sex (male; female).

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: Back to contents list

Specification of MMY data format (2002 overview)

Item Description FORTRAN Columns Details
0  Trial/stratum identifying code  I6  1 - 6 
1  Patient identifier (or sequence number)  A12  8 - 19 
2 Sex I1 21
Value Description Abbreviation
1 Male M
2 Female F
3 Randomisation age I2 23 - 24
4  Date of Birth I8  26 - 33 DDMMYYYY 
5 Date of Diagnosis I8 35- 42 DDMMYYYY
6 Date of Randomisation I8 44 - 51 DDMMYYYY
7  Treatment group allocated (as on master list)  I1  53 
8 Response I1 55
Value Description
1 Complete
2 Partial
3 None
4 Not available
 
9 Date of response I8  57 - 64 DDMMYYYY
10 Did the patient reach plateau phase?  I1 66
Value Discription
1 Yes
2 No
 
11 Date of plateau phase I8 68 - 75 DDMMYYYY
12 Relapse I1 77
Value Discription
1 Yes
2 No
13 Date of relapse I8 79 - 86 DDMMYYYY
14 Current status  I1
 
 
 

 

 88
 
 
 

 
Value Discription
1 Alive
2 Dead
 
15 Date of last follow up I8 90 - 97 DDMMYYYY
16 Cause of Death I2 99 - 100
Value Discription
1 Progressive disease
2 Related to Myeloma
3 Unrelated to Myeloma
17 Durie/Salmon stage I1  102
Value Discription
1 Stage I
2 Stage II
3 Stage III
 
18 Haemoglobin I3 104 - 106 [g/dl], to 1 decimal point, ie ##.#
19 Platelets I4 108 - 111 [*109/l], as an integer
20 Leucocytes I4 113 - 116 [*109/l], to 1 decimal point, ie ###.#
21 ß2-microglobulin I3 118 - 120 [mg/l], to 1 decimal point, ie ##.#
22 M band type A2 122 -123 If two paraproteins are present, please give the type which is present in the larger amount
23 Serum creatinine I5 125 - 129 Please specify units used
24 Serum creatinine unit I1 131
Value Dicription
1 ??unit
25 Uncorrected serum calcium I5 133 - 137 Please specify units used
26 Uncorrected serum calcium unit I1 139
Value Discription
1 ??unit
27 Serum albumin I5 141 - 145 Please specify units used
28 Serum albumin unit I1 147
Value Discription
1 ??unit
29 Bone lesions I1 149 
Value Discription
1 None
2 Minimal
3 Multiple osteilytic lesions
4 Not available
30 Performance status I3 151 - 153 Please use your own codes and specify the coding system used
31 Performance status coding I1 155
Value Discription
1 ??unit
32 Plasmal labelling index I3 157 - 159 to 1 decimal point, ie ##.#
33 C reactive protein I4 161 - 164 to 1 decimal point, ie ###.#
34 Fractures I1 166
Value Discription
1 Yes
2 No
35 Genetic abnormality detected I1 168
Value Discription
1 Yes
2 No
36 Abnormality of chromosome 13 I1 170
Value Discription
1 Yes
2 No
37 Vertebral fractures I1 172
Value Discription
1 Yes
2 No
38 Non-vertebral fractures I1 174
Value Discription
1 Yes
2 No
39 Hypercalcaemia I1 176
Value Discription
1 Yes
2 No
40 Pain I1 178
Value Discription
1 Yes
2 No
41 Toxicity I1 180
Value Discription
1 Yes
2 No
42 Renal disfunction I1  182
Value Discription
1 Yes
2 No
43 name and comments A 184 - end
Missing or unknown items are set to zero except for specified. True value zero is set to '-13'.
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MMY 2002 Data Request

This is a copy of the data request that has been sent out to collaborators.

How to send TRIAL DATA to the Myeloma Trialists’ Collaborative Group

Please include data on all patients ever randomised into the trial(s), whether or not they actually received their allocated treatment. The preferred format for the data is as described on the attached sheet. However, if a different format is more convenient for you, this should cause us no great difficulty, as long as it is clearly specified. If you are sending the data electronically (e.g. as a SAS dataset or Excel spreadsheet) then the precise format does not matter, though it would be helpful if you could list parameters as far as possible in the same order as on the data format sheet.

The easiest way for us to receive the data is by e-mail. Our address is mmy.overview@ctsu.ox.ac.uk
 

OR:  Send the data on electronic media (ideally disk) and enclose a printout of the contents.

OR:  Send a lineprinter listing of the data (preferably with a blank line between each line of data to
         help us avoid punching errors), giving as much as possible of the information
         requested on the data format sheet.

OR:  Do whatever else seems sensible to you. We shall be happy to receive any mixture of
        paper and electronics that contains the necessary information.

For trials previously supplied to the overview; if you would like us to send you a copy of the data we currently hold for your trial so that you can update this, please contact the secretariat.

 Reminder of confidentiality

All data sent to the Myeloma Trialists' Collaborative Group Secretariat will be held securely and treated in the strictest confidence. The data will not be used in any publication without the written permission of the responsible trialist. Data from the autograft trials will also be sent to the Northern and Yorkshire Clinical Trials and Research Unit (NYCTRU), Leeds. Data from the bisphosphonate trials will also be sent to the H Lee Moffitt Cancer Center, Tampa, Florida. These two centres will be joint Secretariat for these respective overviews.

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 Notes on Data Format

1. The first part of the format (up to column 115) is identical to that used for the 1997 overview,
     except that eight digit dates are now used.

2. Five new baseline parameters (columns 116 to 127) have been added. Please supply data if available.

3. Prognostic information (columns 77 to 127) should be at diagnosis (not at randomisation in the case of consolidation or maintenance trials).

4. For the bisphosphonates overview only, six new endpoints have been added (columns 128 to133). These are listed as simple dichotomous
    yes/no parameters. We will contact the relevant trialists to discuss whether any of these variables could be supplied in an alternative way.
 

Example (for illustration purpose):

Myeloma Trialists’ Collaborative Group

TRIALS for which DATA ARE REQUESTED

Group:              32  Southwest Oncology Group (SWOG), USA

Collaborators:   Anderson, Coltman, Crowley, Jacobson, Kyle, Tangen

Trials:                32/12  SWOG 8624 (M): Maintenance, 1987-1990; 299 pts in full trial
                                      2 IFN
                                      1 No further therapy

                           32/16  SWOG 9321 / INT 0141 (IFN): Maintenance, 1994-2000; 245 pts in full trial
                                      2 IFN
                                      1 No further therapy

                            32/17  SWOG 9321 / INT 0141 (BMT): Bone Marrow Transplant, 1994-2000; 555 pts in full trial
                                      1 Mel + TBI + autologous PBSCT + G-CSF
                                      2 Vinc + BCNU + Mel + Cyclo + Pred {VBMCP}
 

Myeloma Trialists’ Collaborative Group DATA FORMAT (2002 Meeting)

Please include one record for eachrandomised patient, even if they did not receive the allocated treatment, were subsequently found to be ineligible, etc. If any item is not available, please leave the relevant column blank. Please see “Notes on Data Format” on attached sheet.

Columns            Parameter
1-12                     Patient identifier
13                        Sex (1=male, 2=female)
14-21                  Date of birth (or age at entry in columns 14-15)
22-29                  Date of diagnosis
30-37                  Date of randomisation
38                        Allocated treatment (please specify)
39                        Response (1=complete, 2=partial, 3=none, 4=not available. Please supply your definitions of response)
40-47                  Date of response
48                        Did the patient reach plateau phase? (1=yes, 2=no)
49-56                  Date of plateau phase
57                        Relapse (1=yes, 2=no, 9=unknown)
58-65                  Date of relapse
66                        Current status (1=alive, 2=dead)
67-74                  Date last known to be alive or date died
75-76                  Cause of death (please use your own codes and specify what they are. As a minimum please try to distinguish
                            between:1.progressive   disease; 2. causes related to myeloma such as infection, renal failure, etc; 3. causes
                            probably unrelated to myeloma)
77                        Durie/Salmon stage (1=stage I, 2=stage II, 3=stage III) or use your own alternative if Durie/Salmon stage is not available
                            (please specify the staging system used)
78-81                  Haemoglobin [g/dl] (to 1 decimal point, ie _ _._)
82-85                  Platelets [x109/l] (as an integer)
86-90                  Leucocytes [x109/l] (to 1 decimal point, ie _ _ _._)
91-94                  ß2-microglobulin [mg/l] (to 1 decimal point, ie _ _._)
95-96                  M band type (if two paraproteins are present, please give the type which is present in the larger amount)
97-101                Serum creatinine (please specify units used)
102-106              Uncorrected serum calcium (please specify units used)
107-111              Serum albumin (please specify units used)
112                      Bone lesions (1=none, 2=minimal, 3=multiple osteolytic lesions, 4=not available)
113-115              Performance status (please use your own codes and specify the coding system used)
116-119              Plasma labelling index (to 1 decimal point, ie _ _._)
120-124              C reactive protein [g/l] (to 1 decimal point, ie _ _ _._)
125                      Fractures (1=yes, 2=no)
126                      Genetic abnormality detected (1=yes, 2=no, 3=not done)
127                      Abnormality of chromosome 13 (1=yes, 2=no, 3=not done)

Bisphosphonates overview only, the following additional endpoints are requested:
128                      Vertebral fractures (1=yes, 2=no)
129                      Non-vertebral fractures (1=yes, 2=no)
130                      Hypercalcaemia (1=yes, 2=no)
131                      Pain (1=yes, 2=no)
132                      Toxicity (1=yes, 2=no)
133                      Renal dysfunction (1=yes, 2=no)

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MMY 2002: All centres/groups, trials/strata and treatments


Myeloma Trialists' Collaborative Group

TRIALS for which DATA ARE REQUESTED

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Galaxy myeloma data directories for 2002 overview

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The procedure for myeloma data importing and checking

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The myeloma web page was last updated by Yaochen on 5th Sept 2001.