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

Form 54 - Change of Medications

File Name	Data as of	Population	Data collected	One row per	Rows
f54_ct_inv.dat	2/17/2024	CT	Main	Form	48,589

ID - WHI Participant Common ID

Col 1

N	Missing
48,589	0

F54DAYS - F54 Days since CT randomization

Col 2

N	Missing	Min	Max	Mean	StdDev
48,589	0	2	3,913	1,158.976	782.316

F54CADDY - F54 Days since CaD randomization

Col 3

Days between CaD randomization and initiation of form

N	Missing	Min	Max	Mean	StdDev
37,405	11,184	-741	3,440	833.606	781.538

F54VTYP - Visit Type

Col 4

Value	Description	N	%
2	Semi-Annual visit	9,838	20.2
3	Annual visit	12,210	25.1
4	Non-Routine visit	26,516	54.6
5	6 week HRT/4 week CaD call	25	0.1

F54VY - Visit year

Col 5

Visit year for which this form was collected.

N	Missing	Min	Max	Mean	StdDev
22,048	26,541	1	11	3.823	2.076

HRT - HRT dosage (pills/week)

Col 6

What is the new study medication schedule? (Include all study medications the participant should take, including those that you are not changing.) HRT dosage (pills/week):

N	Missing	Min	Max	Mean	StdDev
28,080	20,509	0	14	3.791	3.341

CEE3 - CEE 0.3mg dosage (pills/week)

Col 7

What is the new study medication schedule? (Include all study medications the participant should take, including those that you are not changing.) CEE 0.3 mg dosage (pills/week):

N	Missing	Min	Max	Mean	StdDev
492	48,097	0	14	4.629	3.37

CEE625 - CEE 0.625 mg dosage (pills/week)

Col 8

What is the new study medication schedule? (Include all study medications the participant should take, including those that you are not changing.) CEE 0.625 mg dosage (pills/week):

N	Missing	Min	Max	Mean	StdDev
441	48,148	0	14	4.363	3.488

MPA25 - MPA 2.5 mg dosage (pills/week)

Col 9

What is the new study medication schedule? (Include all study medications the participant should take, including those that you are not changing.) MPA 2.5 mg dosage (pills/week):

N	Missing	Min	Max	Mean	StdDev
4,014	44,575	0	56	6.553	4.418

MPA5 - MPA 5 mg dosage (pills/week)

Col 10

What is the new study medication schedule? (Include all study medications the participant should take, including those that you are not changing.) MPA 5 mg dosage (pills/week):

N	Missing	Min	Max	Mean	StdDev
500	48,089	0	28	5.87	3.203

MPA10 - MPA 10 mg dosage (pills/week)

Col 11

What is the new study medication schedule? (Include all study medications the participant should take, including those that you are not changing.) MPA 10 mg dosage (pills/week):

N	Missing	Min	Max	Mean	StdDev
1,202	47,387	0	21	6.204	4.149

CAD - CaD dosage (pills/week)

Col 12

What is the new study medication schedule? (Include all study medications the participant should take, including those that you are not changing.) CaD dosage (pills/week):

N	Missing	Min	Max	Mean	StdDev
28,152	20,437	0	14	6.749	5.687

CYCLIC - Cyclic regimen

Col 13

Is this a cyclic regimen?

Usage Notes:

Not collected on all versions of Form 54.

Value	Description	N	%
0	No	16,786	34.5
1	Yes	506	1
	Missing	31,297	64.4%

PERM - Study medication permanent

Col 14

Is the new study medication schedule permanent?

Value	Description	N	%
0	No	24,022	49.4
1	Yes	23,978	49.3
	Missing	589	1.2%

HOWLONG - How long to take (weeks)

Col 15

For how long should the participant follow this new study medication schedule? (Record shortest length of time if more than one medication.)

Usage Notes:

Sub-question of F54 V3 Q7 "Study medication permanent" (skip pattern rule not applied).

N	Missing	Min	Max	Mean	StdDev
23,046	25,543	0	52	9.33	7.755

HRTBLEED - HRT - bleeding

Col 16

Why did you make the change in the medication schedule? (Mark all that apply). HRT - bleeding:

Value	Description	N	%
0	No	18,949	39
1	Yes	5,751	11.8
	Missing	23,889	49.2%

HRTBIOP - HRT - biopsy abnormality

Col 17

Why did you make the change in the medication schedule? (Mark all that apply). HRT - biopsy abnormality:

Value	Description	N	%
0	No	24,481	50.4
1	Yes	219	0.5
	Missing	23,889	49.2%

HRTTVU - HRT - abnormal transvaginal ultrasound

Col 18

Why did you make the change in the medication schedule? (Mark all that apply). HRT - abnormal transvaginal ultrasound:

Value	Description	N	%
0	No	24,611	50.7
1	Yes	89	0.2
	Missing	23,889	49.2%

HRTSYMP - HRT - symptom intolerance

Col 19

Why did you make the change in the medication schedule? (Mark all that apply). HRT - symptom intolerance:

Value	Description	N	%
0	No	19,964	41.1
1	Yes	4,736	9.7
	Missing	23,889	49.2%

HRTOTHER - HRT - other

Col 20

Why did you make the change in the medication schedule? (Mark all that apply). HRT - other:

Value	Description	N	%
0	No	9,515	19.6
1	Yes	15,185	31.3
	Missing	23,889	49.2%

CADSYMP - CaD - symptom intolerance

Col 21

Why did you make the change in the medication schedule? (Mark all that apply). CAD - symptom intolerance:

Value	Description	N	%
0	No	13,812	28.4
1	Yes	8,867	18.2
	Missing	25,910	53.3%

CADOTHER - CaD - other

Col 22

Why did you make the change in the medication schedule? (Mark all that apply). CAD - other:

Value	Description	N	%
0	No	8,194	16.9
1	Yes	14,485	29.8
	Missing	25,910	53.3%