This document can be used to prepare or evaluate feasibility of ancillary study proposals and paper proposals, but is NOT intended for publication.

Form 10 & 50 - HRT Management and Safety Interview, Report of Vaginal Bleeding

File NameData as ofPopulationData collectedOne row perRows
f10_50_ht_inv.dat9/12/2005HTMainForm330,977
ID - WHI Participant Common ID
Col 1
NMissing
330,9770
F1050DYS - F10/50 Days since randomization
Col 2
Days between randomization and initiation of form
NMissingMinMaxMeanStdDev
330,977024,0411,205.809856.192
F1050VTYP - Visit Type
Col 3
ValueDescriptionN%
1Screening00
2Semi-Annual visit153,01246.2
3Annual visit142,61243.1
4Non-Routine visit9,2602.8
56 week HRT/4 week CaD call26,0937.9
6Diet Intervention00
7Interim 33/33D00
8Amendment 33/33D00
F1050VY - Visit year
Col 4
Visit year for which this form was collected.
NMissingMinMaxMeanStdDev
295,62335,3541113.8732.234
HYST - Had a hysterectomy
Col 5
Has the participant had a hysterectomy?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No188,35856.9
1Yes132,56640.1
Missing10,0533%
VAGBLEED - Had vaginal bleeding
Col 6
ValueDescriptionN%
0No299,58690.5
1Yes27,4128.3
Missing3,9791.2%
HEAVYBLD - How heavy was vaginal bleeding
Col 7
Usage Notes: Not collected on all versions of Form 10.
ValueDescriptionN%
1Spotting - approx 1 pad/day19,1115.8
2Light - 2 or 3 pads/day3,3171
3Moderate - 4 to 7 pads/day2,3600.7
4Severe - 8 or more pads/day3320.1
Missing305,85792.4%
STARTDY - Days from randomization to vaginal bleeding start
Col 8
Usage Notes: Not collected on all versions of Form 10.
NMissingMinMaxMeanStdDev
24,618306,359-3503,466586.714654.989
INTERMIT - Did vaginal bleeding start and stop again
Col 9
Usage Notes: Not collected on all versions of Form 10. Not collected on all versions of Form 50.
ValueDescriptionN%
0No7,8622.4
1Yes16,8515.1
Missing306,26492.5%
BLEEDNOW - Are you bleeding from the vagina now
Col 10
Usage Notes: Not collected on all versions of Form 10.
ValueDescriptionN%
0No20,5796.2
1Yes4,6671.4
Missing305,73192.4%
STOPDY - Days from randomization to vaginal bleeding stop
Col 11
Usage Notes: Not collected on all versions of Form 10. Sub-question of "Are you bleeding from the vagina now".
NMissingMinMaxMeanStdDev
19,124311,853-3273,468663.08655.89
BRSTTEND - Had any breast tenderness
Col 12
Since your last contact, have you had any breast tenderness?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No133,99840.5
1Yes11,0143.3
Missing185,96556.2%
SEVTEND - Breast tenderness severity
Col 13
Was your breast tenderness mild, moderate, or severe?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50. Sub-question of F10 V7 Q7 "Had any breast tenderness"
ValueDescriptionN%
1Mild8,2242.5
2Moderate2,1590.7
3Severe4670.1
Missing320,12796.7%
BRSTCHNG - Any changes in your breasts
Col 14
Have you noticed any changes in your breasts (new lumps, nipple discharge, or skin changes)?
Usage Notes: Not collected on Form 50.
ValueDescriptionN%
0No317,03295.8
1Yes9,6072.9
Missing4,3381.3%
CORTICOS - Taking or prescribed Corticosteroids
Col 15
Are you now taking, or has a doctor prescribed, any Corticosteroids (such as Prednisone, Decadron, Medrol in pill form)?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No299,15690.4
1Yes3,4831.1
Missing28,3388.6%
ANTICOAG - Taking or prescribed blood thinning medications
Col 16
Are you now taking, or has a doctor prescribed any blood thinning medications (such as Coumadin or Warfarin)?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No298,73690.3
1Yes3,7131.1
Missing28,5288.6%
ESTROGEN - Taking or prescribed Estrogen
Col 17
Are you now taking, or has a doctor prescribed Estrogen?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No296,90089.7
1Yes5,7021.7
Missing28,3758.6%
PROGEST - Taking or prescribed Progesterone
Col 18
Are you now taking, or has a doctor prescribed Progesterone?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No300,05290.7
1Yes2,4420.7
Missing28,4838.6%
TESTOST - Taking or prescribed Testosterone
Col 19
Are you now taking, or has a doctor prescribed Testosterone?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No302,18391.3
1Yes1990.1
Missing28,5958.6%
TAMOXIF - Taking or prescribed Tamoxifen
Col 20
Are you now taking, or has a doctor prescribed Tamoxifen, Raloxifene (Evista) or other medications know as SERMS?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No301,08591
1Yes1,2830.4
Missing28,6098.6%
ENDOHYP - Endometrial hyperplasia
Col 21
Since your last contact has a doctor told you that you had Endometrial hyperplasia?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No300,15390.7
1Yes1900.1
Missing30,6349.3%
HIGHTRIG - High triglycerides in blood
Col 22
Since your last contact has a doctor told you that you had high triglycerides in your blood (triglycerides are not the same as cholesterol)?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No294,72389
1Yes7,4392.2
Missing28,8158.7%
TRIG1000 - Were your triglycerides over 1000 (mg/dl)
Col 23
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50. Sub-question of F10 V7 Q11.2 "High triglycerides in blood".
ValueDescriptionN%
0No5,0371.5
1Yes500
Missing325,89098.5%
BLDCLOT - Blood clot to your leg or lung
Col 24
Since your last contact has a doctor told you that you had a blood clot to your leg or lung?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No301,77791.2
1Yes6570.2
Missing28,5438.6%
MELANOMA - Melanoma of skin
Col 25
Since your last contact has a doctor told you that you had melanoma of skin?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No302,19991.3
1Yes2290.1
Missing28,5498.6%
HEARTSTK - Heart attack or stroke
Col 26
Since your last contact has a doctor told you that you had a heart attack or stroke?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No301,04291
1Yes1,3560.4
Missing28,5798.6%
MENINGIO - Meningioma, or tumors in the brain
Col 27
Since your last contact has a doctor told you that you had meningioma, or tumors in the brain?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No302,09391.3
1Yes1770.1
Missing28,7078.7%
BRSTCANC - Breast cancer
Col 28
Since your last contact has a doctor told you that you had breast cancer?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No144,35243.6
1Yes4310.1
Missing186,19456.3%
GALLBLAD - Gall bladder disease
Col 29
Since your last contact has a doctor told you that you had gall bladder disease?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No71,96421.7
1Yes3700.1
Missing258,64378.1%
PANCREAS - Problems with your pancreas
Col 30
Since your last contact has a doctor told you that you had problems with your pancreas?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No72,16121.8
1Yes1160
Missing258,70078.2%
CONTMEDS - Participant advised to continue study medications
Col 31
Resulting action from participant reports of symptoms or concerns: Participant reassured and advised to continue with current study medications.
Usage Notes: Not collected on all versions of Form 10.
ValueDescriptionN%
0No56,65917.1
1Yes190,66757.6
Missing83,65125.3%
RTRNEVAL - Participant advised to return for evaluation
Col 32
Resulting action from participant reports of symptoms or concerns: Participant advised to return to clinic for evaluation.
Usage Notes: Not collected on all versions of Form 10.
ValueDescriptionN%
0No246,21374.4
1Yes1,1130.3
Missing83,65125.3%
GYNNOTE - Consulting gynecologist notified
Col 33
Resulting action from participant reports of symptoms or concerns: Consulting gynecologist notified.
Usage Notes: Not collected on all versions of Form 10.
ValueDescriptionN%
0No244,91174
1Yes2,4150.7
Missing83,65125.3%
PHYSNOTE - Participant referred to primary physician
Col 34
Resulting action from participant reports of symptoms or concerns: Participant referred to primary physician.
Usage Notes: Not collected on all versions of Form 10.
ValueDescriptionN%
0No246,10274.4
1Yes1,2240.4
Missing83,65125.3%
MEDCHNG - Medications changed or stopped
Col 35
Resulting action from participant reports of symptoms or concerns: Medications changed or stopped.
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No235,98971.3
1Yes9,9703
Missing85,01825.7%
OTHERACT - Other action taken
Col 36
Resulting action from participant reports of symptoms or concerns: Other.
Usage Notes: Not collected on all versions of Form 10.
ValueDescriptionN%
0No198,30559.9
1Yes49,02114.8
Missing83,65125.3%
PILLFREQ - How often did you take the study pills
Col 37
Since your last contact, how often did you take the study pills?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0Not at all41,86212.6
1Less than once per week6750.2
21 - 2 days per week9900.3
33 - 4 days per week5,2771.6
45 - 6 days per week9,8323
5Every day of the week245,37474.1
Missing26,9678.1%
DAYSMISS - How many days missed taking pills in last month
Col 38
About how many days have you missed taking your pills in the last month?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
NMissingMinMaxMeanStdDev
274,85956,1180314.6369.889
ALLPILLS - Took all pills every day
Col 39
If there were days you did not take the pills, what were the reasons you didnt: Took all pills every day
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No115,23934.8
1Yes162,76449.2
Missing52,97416%
EXPSYMP - Experienced symptoms
Col 40
If there were days you did not take the pills, what were the reasons you didnt: Experienced symptoms
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No274,50182.9
1Yes3,5021.1
Missing52,97416%
FRGTPILL - Forgot pill(s)
Col 41
If there were days you did not take the pills, what were the reasons you didnt: Forgot pill(s)
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No218,87866.1
1Yes59,12517.9
Missing52,97416%
FRGTBOTL - Forgot bottle
Col 42
If there were days you did not take the pills, what were the reasons you didnt: Forgot bottle
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No274,60483
1Yes3,3991
Missing52,97416%
TOOKBRK - Needed/Took a break
Col 43
If there were days you did not take the pills, what were the reasons you didnt: Needed/Took a break
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No275,97283.4
1Yes2,0310.6
Missing52,97416%
AFRAID - Afraid of health problems
Col 44
If there were days you did not take the pills, what were the reasons you didnt: Afraid of health problems
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No275,38983.2
1Yes2,6140.8
Missing52,97416%
FAMRCMND - Family/Friend recommendation
Col 45
If there were days you did not take the pills, what were the reasons you didnt: Family/Friend recommendation
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No277,87284
1Yes1310
Missing52,97416%
MDRCMND - MD recommendation
Col 46
If there were days you did not take the pills, what were the reasons you didnt: MD recommendation
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No273,03782.5
1Yes4,9661.5
Missing52,97416%
NOPILLS - Didn`t have any pills
Col 47
If there were days you did not take the pills, what were the reasons you didnt: Didnt have any pills
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No272,15182.2
1Yes5,8521.8
Missing52,97416%
OTHRMISS - Other reason for missing pills
Col 48
If there were days you did not take the pills, what were the reasons you didnt: Other
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No226,51368.4
1Yes51,49015.6
Missing52,97416%
IAP - Should be put on Intensive Adherence Program
Col 49
Should participant be put on Intensive Adherence Program (IAP)?
Usage Notes: Not collected on all versions of Form 10. Not collected on Form 50.
ValueDescriptionN%
0No269,84081.5
1Yes5,4901.7
Missing55,64716.8%
RECONTAC - Should participant be recontacted in one month
Col 50
Should participant be recontacted in one month by phone for clinical follow-up
Usage Notes: Not collected on all versions of Form 10.
ValueDescriptionN%
0No247,84674.9
1Yes7,0802.1
Missing76,05123%