9.2.2: Chronic Transfusion Summary – “Form” 85 A. Collection Information: In order to facilitate retrieval of information about on-study chronic transfusion treatment so that patients who were chronically transfused during a significant proportion of time on study during Phase 1 could be identified, the number of transfusion visit records (See Section 9.2.1, SAS dataset R84.SD2) during each year of follow-up was calculated. Phase 1 study entry date (See Section 1, SAS dataset: R09.SD2, variable: DOE) was used as the starting date. A transfusion occurring within 3 days following another transfusion was not counted as a “unique” transfusion. A “Record 85” was created only for full protocol patients (See Section 1, SAS dataset: R09.SD2, variable: PTYPE). B. Data Collection Period: 03/79 – 09/88 Source of Data: Form 84: Transfusion (See Section 9.2.1, SAS dataset: R84.SD2) C. Form Version Dates: See Section 9.2.1 D. Files Used to Store Information: SAS System File: R85.SD2 Format File: R85.FMT E. Unique Record Identifiers: ANONID F. Number of Observations (Patients) in SAS Dataset: 3897 (3897) G. Contents of SAS Dataset: Alphabetical Listing of Variables: See pp. 52-53 Listing of Variables by Position: See p. 54 H. Notes About Selected Variables: None (See I. below) I. Computed Variables: All STOPDATE – is the variable name for end of follow-up for transfusion. The value of the variable = STATUSD in R09.SD2 (See Section 1). TXENTRY – is the variable name for whether or not the patient was transfused at entry. Transfusion questions on entry past medical history forms and entry SECTION 9.2.2 CHRONIC TRANSFUSION HISTORY ”FORM” 85 49 9.2.2: Chronic Transfusion Summary – “Form” 85 routine visit forms were used to determine whether or not the patient was transfused at entry (See TXENTRYS). TXENTRYS – is the variable name for the source of information which was used to determine if a patient was transfused at entry (see TXENTRY). Entry past medical history forms and routine entry visit forms were used as the sources of information for response for this variable. TIMEYR1-10 – are variable names for time on study during each year of followup during Phase 1 up to 10 years after study entry. The unit of measurement for all time variables is days. Variables DOE and STATUSD in R09.SD2 were used to compute the # of days on transfusion during each year of follow-up during Phase 1. TXYR1-10 – are variable names for the # of transfusions given during each year of follow-up up to 10 years during Phase 1. The number of transfusions reported on Form 84 (SAS dataset: R84.SD2) within each 1 year interval from the patient’s date of entry (DOE in R09.SD2) during the number of years he/she was followed during Phase 1 was calculated (excluding those within 3 days of a previous transfusion). TOTTIME – is the variable name for the total follow-up time (in days) that a patient was followed during Phase 1: STOPDATE – DOE. TOTTX – is the variable name for total # of transfusions given between DOE and STOPDATE excluding those given within 3 days of a previous transfusion. J. Inter-Relationship With Other Datasets: On-study transfusions were collected on: CSSCD Phase 1 Forms Form 84 SAS Dataset See Section R84.SD2 9.2.1 Study entry transfusion status and/or transfusion history data were collected on CSSCD Phase 1 Forms SAS Dataset See Section Form 10 Form 14 Form 15 Form 16 Form 16E Form 12 Forms 17, 19, 20, 21, 24 R10.SD2 R14.SD2 R15.SD2 R16.SD2 R24.SD2 R1222.SD2 R1722.SD2 2.3 2.1 2.2 4.1 4.2 4.4 4.5 SECTION 9.2.2 CHRONIC TRANSFUSION HISTORY ”FORM” 85 50 9.2.2: Chronic Transfusion Summary – “Form” 85 R25.SD2 Form 25 4.6 Transfusion status preceding and/or for clinical events was collected on the majority of clinical event forms: CSSCD Phase 1 Forms SAS Dataset Multiple Multiple See Section SECTION 9.2.2 CHRONIC TRANSFUSION HISTORY ”FORM” 85 51 7 CODEBOOK FOR CSSCD “FORM” 85 CHRONIC TRANSFUSION HISTORY CSSCD FULL COHORT PATIENTS CONTENTS OF SAS DATASET: R85.SD2 DATA FROM CSSCD RECORD 85 - CHRONIC TRANSFUSION SUMMARY VARIABLES ARE LISTED IN ALPHABETICAL ORDER AND IN ORDER OF THEIR POSITION IN THE SAS DATASET 09:09 Monday, September 11, 2000 CONTENTS PROCEDURE Data Set Name: Member Type: Engine: Created: Last Modified: Protection: Data Set Type: Label: OUT.R85 DATA V612 9:47 Monday, September 11, 2000 9:47 Monday, September 11, 2000 Observations: Variables: Indexes: Observation Length: Deleted Observations: Compressed: Sorted: 3897 30 0 240 0 NO YES -----Engine/Host Dependent Information----Data Set Page Size: Number of Data Set Pages: File Format: First Data Page: Max Obs per Page: Obs in First Data Page: 8192 116 607 1 34 17 -----Alphabetic List of Variables and Attributes----# Variable Type Len Pos Label -------------------------------------------------------------------------1 ANONID Char 8 0 ANONYMIZED ID # 27 CTSTAT Num 8 208 CHRONIC TRANSFUSION STATUS 28 F85UTIL1 Num 8 216 UTILITY VARIABLE 1 29 F85UTIL2 Num 8 224 UTILITY VARIABLE 2 30 F85UTILD Num 8 232 UTILITY DATE VARIABLE 2 STOPDATE Num 8 8 END OF FU FOR TRANSFUSIONS 5 TIMEYR1 Num 8 32 YEAR 1 - TIME ON STUDY 7 TIMEYR2 Num 8 48 YEAR 2 - TIME ON STUDY 9 TIMEYR3 Num 8 64 YEAR 3 - TIME ON STUDY 11 TIMEYR4 Num 8 80 YEAR 4 - TIME ON STUDY 13 TIMEYR5 Num 8 96 YEAR 5 - TIME ON STUDY 15 TIMEYR6 Num 8 112 YEAR 6 - TIME ON STUDY 17 TIMEYR7 Num 8 128 YEAR 7 - TIME ON STUDY 19 TIMEYR8 Num 8 144 YEAR 8 - TIME ON STUDY 21 TIMEYR9 Num 8 160 YEAR 9 - TIME ON STUDY 23 TIMEYR10 Num 8 176 YEAR 10 - TIME ON STUDY 25 TOTTIME Num 8 192 TOTAL FOLLOW-UP TIME (TO STOPDATE) 26 TOTTX Num 8 200 TOTAL # OF ON-STUDY TRANSFUSIONS 3 TXENTRY Num 8 16 TRANSFUSED AT ENTRY 4 TXENTRYS Num 8 24 SOURCE OF ENTRY TRANSF. STATUS 6 TXYR1 Num 8 40 YEAR 1 - # OF TRANSFUSIONS 8 TXYR2 Num 8 56 YEAR 2 - # OF TRANSFUSIONS 10 TXYR3 Num 8 72 YEAR 3 - # OF TRANSFUSIONS 12 TXYR4 Num 8 88 YEAR 4 - # OF TRANSFUSIONS SECTION 9.2.2 CHRONIC TRANSFUSION HISTORY ”FORM” 85 52 CODEBOOK FOR CSSCD “FORM” 85 CHRONIC TRANSFUSION HISTORY CSSCD FULL COHORT PATIENTS CONTENTS OF SAS DATASET: R85.SD2 DATA FROM CSSCD RECORD 85 - CHRONIC TRANSFUSION SUMMARY VARIABLES ARE LISTED IN ALPHABETICAL ORDER AND IN ORDER OF THEIR POSITION IN THE SAS DATASET 09:09 Monday, September 11, 2000 CONTENTS PROCEDURE # Variable Type Len Pos Label -------------------------------------------------------------------------14 TXYR5 Num 8 104 YEAR 5 - # OF TRANSFUSIONS 16 TXYR6 Num 8 120 YEAR 6 - # OF TRANSFUSIONS 18 TXYR7 Num 8 136 YEAR 7 - # OF TRANSFUSIONS 20 TXYR8 Num 8 152 YEAR 8 - # OF TRANSFUSIONS 22 TXYR9 Num 8 168 YEAR 9 - # OF TRANSFUSIONS 24 TXYR10 Num 8 184 YEAR 10 - # OF TRANSFUSIONS SECTION 9.2.2 CHRONIC TRANSFUSION HISTORY ”FORM” 85 53 CODEBOOK FOR CSSCD “FORM” 85 CHRONIC TRANSFUSION HISTORY CSSCD FULL COHORT PATIENTS CONTENTS OF SAS DATASET: R85.SD2 DATA FROM CSSCD RECORD 85 - CHRONIC TRANSFUSION SUMMARY VARIABLES ARE LISTED IN ALPHABETICAL ORDER AND IN ORDER OF THEIR POSITION IN THE SAS DATASET 09:09 Monday, September 11, 2000 CONTENTS PROCEDURE -----Variables Ordered by Position----# Variable Type Len Pos Label -------------------------------------------------------------------------1 ANONID Char 8 0 ANONYMIZED ID # 2 STOPDATE Num 8 8 END OF FU FOR TRANSFUSIONS 3 TXENTRY Num 8 16 TRANSFUSED AT ENTRY 4 TXENTRYS Num 8 24 SOURCE OF ENTRY TRANSF. STATUS 5 TIMEYR1 Num 8 32 YEAR 1 - TIME ON STUDY 6 TXYR1 Num 8 40 YEAR 1 - # OF TRANSFUSIONS 7 TIMEYR2 Num 8 48 YEAR 2 - TIME ON STUDY 8 TXYR2 Num 8 56 YEAR 2 - # OF TRANSFUSIONS 9 TIMEYR3 Num 8 64 YEAR 3 - TIME ON STUDY 10 TXYR3 Num 8 72 YEAR 3 - # OF TRANSFUSIONS 11 TIMEYR4 Num 8 80 YEAR 4 - TIME ON STUDY 12 TXYR4 Num 8 88 YEAR 4 - # OF TRANSFUSIONS 13 TIMEYR5 Num 8 96 YEAR 5 - TIME ON STUDY 14 TXYR5 Num 8 104 YEAR 5 - # OF TRANSFUSIONS 15 TIMEYR6 Num 8 112 YEAR 6 - TIME ON STUDY 16 TXYR6 Num 8 120 YEAR 6 - # OF TRANSFUSIONS 17 TIMEYR7 Num 8 128 YEAR 7 - TIME ON STUDY 18 TXYR7 Num 8 136 YEAR 7 - # OF TRANSFUSIONS 19 TIMEYR8 Num 8 144 YEAR 8 - TIME ON STUDY 20 TXYR8 Num 8 152 YEAR 8 - # OF TRANSFUSIONS 21 TIMEYR9 Num 8 160 YEAR 9 - TIME ON STUDY 22 TXYR9 Num 8 168 YEAR 9 - # OF TRANSFUSIONS 23 TIMEYR10 Num 8 176 YEAR 10 - TIME ON STUDY 24 TXYR10 Num 8 184 YEAR 10 - # OF TRANSFUSIONS 25 TOTTIME Num 8 192 TOTAL FOLLOW-UP TIME (TO STOPDATE) 26 TOTTX Num 8 200 TOTAL # OF ON-STUDY TRANSFUSIONS 27 CTSTAT Num 8 208 CHRONIC TRANSFUSION STATUS 28 F85UTIL1 Num 8 216 UTILITY VARIABLE 1 29 F85UTIL2 Num 8 224 UTILITY VARIABLE 2 30 F85UTILD Num 8 232 UTILITY DATE VARIABLE -----Sort Information----Sortedby: ANONID Validated: YES Character Set: ANSI **************************************************************************** * R85.FMT contains value labels for numerical codes assigned to categorical* * variables in the SAS dataset R85.SD2 * ***************************************************************************; * SIR/DBMS 2.2 SAS PROC STEP FROM DATABASE: CSSCD 12/25/99 10:16:23; PROC FORMAT PRINT; SECTION 9.2.2 CHRONIC TRANSFUSION HISTORY ”FORM” 85 54 CODEBOOK FOR CSSCD “FORM” 85 CHRONIC TRANSFUSION HISTORY CSSCD FULL COHORT PATIENTS * FORMAT TXENTRY IS DEFINED FOR VARIABLE TXENTRY; VALUE TXENTRY 1 2 * = 'NO' = 'YES'; FORMAT TXENTRYS IS DEFINED FOR VARIABLE TXENTRYS; VALUE TXENTRY 10 12 14 16 24 = = = = = 'PMH 'LAB 'YNG 'INF 'INF FORM 10' FORM 12' INF FORM 14' INT FORM 16' INT FORM 16E'; SECTION 9.2.2. CHRONIC TRANSFUSION HISTORY “FORM” 85 2 CODEBOOK FOR CSSCD “FORM” 85 CHRONIC TRANSFUSION HISTORY CSSCD FULL COHORT PATIENTS TXENTRY --------------------------------------------------- TRANSFUSED AT ENTRY type: numeric (float) label: TXENTRY range: [1,2] units: 1 unique values: 2 coded missing: 286 / 3897 tabulation: Freq. 3305 306 Numeric 1 2 Label NO YES TXENTRY: 1. Computed variable - see documentation. TXENTRYS --------------------------------------- SOURCE OF ENTRY TRANSF. STATUS type: numeric (float) label: TXENTRYS range: [10,24] units: 1 unique values: 4 coded missing: 286 / 3897 tabulation: Freq. 1354 1607 554 96 Numeric 10 12 14 24 Label PMH FORM 10 LAB FORM 12 YNG INF FORM 14 INF INT FORM 16E TIMEYR1 ------------------------------------------------ YEAR 1 - TIME ON STUDY type: numeric (float) range: [9,365] units: 1 unique values: 138 coded missing: 0 / 3897 mean: std. dev: percentiles: 353.843 48.6073 10% 365 25% 365 50% 365 75% 365 90% 365 TXYR1 ---------------------------------------------- YEAR 1 - # OF TRANSFUSIONS type: numeric (float) range: [0,26] units: 1 unique values: 23 coded missing: 0 / 3897 tab: Freq. 3395 266 65 29 15 16 Value 0 1 2 3 4 5 tab: Freq. 17 15 9 14 4 10 Value 6 7 8 9 10 11 tab: Freq. 9 5 10 4 3 3 Value 12 13 14 15 16 18 TXYR1: 1. Computed variable - see documentation. SECTION 9.2.2. CHRONIC TRANSFUSION HISTORY “FORM” 85 56 tab: Freq. 2 1 3 1 1 Value 19 21 23 25 26 CODEBOOK FOR CSSCD “FORM” 85 CHRONIC TRANSFUSION HISTORY CSSCD FULL COHORT PATIENTS TIMEYR2 ------------------------------------------------ YEAR 2 - TIME ON STUDY type: numeric (float) range: unique values: mean: std. dev: [0,365] 156 units: coded missing: 1 0 / 3897 329.918 100.771 percentiles: 10% 194 25% 365 50% 365 75% 365 90% 365 TXYR2 ---------------------------------------------- YEAR 2 - # OF TRANSFUSIONS type: numeric (float) range: unique values: tabulation: [0,25] 25 Freq. 3397 248 69 42 24 10 8 10 5 10 12 15 11 12 3 2 3 3 4 3 1 1 1 2 1 units: coded missing: 1 0 / 3897 Value 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 21 22 23 24 25 TXYR2: 1. Computed variable - see documentation. SECTION 9.2.2. CHRONIC TRANSFUSION HISTORY “FORM” 85 57 CODEBOOK FOR CSSCD “FORM” 85 CHRONIC TRANSFUSION HISTORY CSSCD FULL COHORT PATIENTS TIMEYR3 ------------------------------------------------ YEAR 3 - TIME ON STUDY type: numeric (float) range: unique values: mean: std. dev: [0,365] 159 units: coded missing: 1 0 / 3897 309.465 126.247 percentiles: 10% 0 25% 365 50% 365 75% 365 90% 365 TXYR3 ---------------------------------------------- YEAR 3 - # OF TRANSFUSIONS type: numeric (float) range: unique values: tabulation: [0,22] 22 Freq. 3388 242 94 37 22 12 11 9 8 6 8 13 12 6 9 4 2 3 4 4 1 2 units: coded missing: 1 0 / 3897 Value 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 21 22 TXYR3: 1. Computed variable - see documentation. SECTION 9.2.2. CHRONIC TRANSFUSION HISTORY “FORM” 85 58 CODEBOOK FOR CSSCD “FORM” 85 CHRONIC TRANSFUSION HISTORY CSSCD FULL COHORT PATIENTS TIMEYR4 ------------------------------------------------ YEAR 4 - TIME ON STUDY type: numeric (float) range: unique values: mean: std. dev: [0,365] 166 units: coded missing: 1 0 / 3897 288.99 143.465 percentiles: 10% 0 25% 365 50% 365 75% 365 90% 365 TXYR4 ---------------------------------------------- YEAR 4 - # OF TRANSFUSIONS type: numeric (float) range: unique values: tabulation: [0,23] 23 Freq. 3444 213 72 27 24 17 11 8 4 13 9 12 8 12 5 3 4 5 2 1 1 1 1 units: coded missing: 1 0 / 3897 Value 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 21 22 23 TXYR4: 1. Computed variable - see documentation. SECTION 9.2.2. CHRONIC TRANSFUSION HISTORY “FORM” 85 59 CODEBOOK FOR CSSCD “FORM” 85 CHRONIC TRANSFUSION HISTORY CSSCD FULL COHORT PATIENTS TIMEYR5 ------------------------------------------------ YEAR 5 - TIME ON STUDY type: numeric (float) range: unique values: mean: std. dev: [0,365] 184 units: coded missing: 1 0 / 3897 264.088 157.841 percentiles: 10% 0 25% 71 50% 365 75% 365 90% 365 TXYR5 ---------------------------------------------- YEAR 5 - # OF TRANSFUSIONS type: numeric (float) range: unique values: tabulation: [0,23] 20 Freq. 3463 217 73 36 14 13 14 12 6 8 12 3 6 5 6 2 2 3 1 1 units: coded missing: 1 0 / 3897 Value 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 23 TXYR5: 1. Computed variable - see documentation. SECTION 9.2.2. CHRONIC TRANSFUSION HISTORY “FORM” 85 60 CODEBOOK FOR CSSCD “FORM” 85 CHRONIC TRANSFUSION HISTORY CSSCD FULL COHORT PATIENTS TIMEYR6 ------------------------------------------------ YEAR 6 - TIME ON STUDY type: numeric (float) range: unique values: mean: std. dev: [0,365] 288 units: coded missing: 1 0 / 3897 217.481 165.841 percentiles: 10% 0 25% 0 50% 348 75% 365 90% 365 TXYR6 ---------------------------------------------- YEAR 6 - # OF TRANSFUSIONS type: numeric (float) range: unique values: tabulation: [0,17] 18 Freq. 3554 177 46 29 12 8 12 6 12 9 2 10 5 7 3 1 1 3 units: coded missing: 1 0 / 3897 Value 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 TXYR6: 1. Computed variable - see documentation. SECTION 9.2.2. CHRONIC TRANSFUSION HISTORY “FORM” 85 61 CODEBOOK FOR CSSCD “FORM” 85 CHRONIC TRANSFUSION HISTORY CSSCD FULL COHORT PATIENTS TIMEYR7 ------------------------------------------------ YEAR 7 - TIME ON STUDY type: numeric (float) range: [0,365] units: 1 unique values: 294 coded missing: 0 / 3897 mean: 116.459 std. dev: 147.009 percentiles: 10% 25% 50% 75% 90% 0 0 0 263 365 TXYR7 ---------------------------------------------- YEAR 7 - # OF TRANSFUSIONS type: numeric (float) range: [0,13] units: 1 unique values: 14 coded missing: 0 / 3897 tabulation: Freq. Value tabulation: Freq. Value 3683 0 7 7 103 1 7 8 27 2 5 9 26 3 5 10 13 4 4 11 6 5 2 12 6 6 3 13 TXYR7: 1. Computed variable - see documentation. TIMEYR8 ------------------------------------------------ YEAR 8 - TIME ON STUDY type: numeric (float) range: [0,365] units: 1 unique values: 108 coded missing: 0 / 3897 mean: 15.4039 std. dev: 59.6873 percentiles: 10% 25% 50% 75% 90% 0 0 0 0 37 TXYR8 ---------------------------------------------- YEAR 8 - # OF TRANSFUSIONS type: numeric (float) range: [0,12] units: 1 unique values: 7 coded missing: 0 / 3897 tabulation: Freq. Value 3861 0 21 1 8 2 1 3 2 4 3 10 1 12 TXYR8: 1. Computed variable - see documentation. SECTION 9.2.2. CHRONIC TRANSFUSION HISTORY “FORM” 85 62 CODEBOOK FOR CSSCD “FORM” 85 CHRONIC TRANSFUSION HISTORY CSSCD FULL COHORT PATIENTS TIMEYR9 ------------------------------------------------ YEAR 9 - TIME ON STUDY type: numeric (float) range: [0,365] units: 1 unique values: 39 coded missing: 0 / 3897 mean: 6.04799 std. dev: 43.1932 percentiles: 10% 0 25% 0 50% 0 75% 0 90% 0 TXYR9 ---------------------------------------------- YEAR 9 - # OF TRANSFUSIONS type: numeric (float) range: [0,14] units: 1 unique values: 6 coded missing: 0 / 3897 tabulation: Freq. Value 3891 0 2 1 1 2 1 8 1 12 1 14 TXYR9: 1. Computed variable - see documentation. TIMEYR10 ---------------------------------------------- YEAR 10 - TIME ON STUDY type: numeric (float) range: [0,264] units: 1 unique values: 34 coded missing: 0 / 3897 mean: 1.13369 std. dev: 14.4253 percentiles: 10% 25% 50% 75% 90% 0 0 0 0 0 TXYR10 -------------------------------------------- YEAR 10 - # OF TRANSFUSIONS type: numeric (float) range: [0,2] units: 1 unique values: 2 coded missing: 0 / 3897 tabulation: Freq. Value 3896 0 1 2 TXYR10: 1. Computed variable - see documentation. TOTTIME ------------------------------------ TOTAL FOLLOW-UP TIME (TO STOPDATE) type: numeric (float) range: [9,3551] units: 1 unique values: 1553 coded missing: 0 / 3897 mean: 1903.8 std. dev: 758.327 percentiles: 10% 25% 50% 75% 90% 559 1532 2174 2454 2594 SECTION 9.2.2. CHRONIC TRANSFUSION HISTORY “FORM” 85 63 CODEBOOK FOR CSSCD “FORM” 85 CHRONIC TRANSFUSION HISTORY CSSCD FULL COHORT PATIENTS TOTTX ---------------------------------------- TOTAL # OF ON-STUDY TRANSFUSIONS type: numeric (float) range: [0,119] units: 1 unique values: 80 coded missing: 0 / 3897 tab: Freq. Value tab: Freq. Value tab: 2490 0 4 27 512 1 3 28 255 2 3 29 133 3 5 30 96 4 4 31 62 5 1 32 48 6 4 33 21 7 4 34 25 8 6 35 21 9 2 36 22 10 1 37 11 11 3 39 8 12 3 40 14 13 2 41 7 14 1 42 9 15 3 43 8 16 3 44 3 17 2 45 8 18 3 46 6 19 3 49 5 20 1 52 7 21 4 53 4 22 1 54 4 23 1 55 2 24 4 56 2 25 1 58 3 26 1 60 TOTTX: 1. Computed variable - see documentation. _dta: 1. Created 8/9/2000. SECTION 9.2.2. CHRONIC TRANSFUSION HISTORY “FORM” 85 64 Freq. 4 1 1 2 1 2 2 2 1 1 1 2 2 2 2 1 2 1 1 1 1 1 1 1 1 1 Value 61 62 63 65 66 67 68 69 70 71 72 75 76 77 78 81 82 88 92 94 103 106 107 115 118 119