Anticipated Side Effects and Health Status Questionnaire

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ID NUMBER:

Anticipated Side Effects and Health Status Questionnaire

FORM CODE: ASE

VERSION:A 01/27/10

Contact

Occasion

0 1 SEQ #

Administrative Information

0a. Completion Date:

Month

/

Day

/

Year

0b. Staff ID:

Instructions: The assessor/study coordinator asks the participant the questions on this form at the baseline visit. Affix the participant

ID label above.

PROMPT : “In the last week, have you experienced any of the following symptoms? If Yes , how frequently did you experience the symptom over the last week?

In the last week, have you experienced…

Yes No Once

Occasionally

(2-4 times)

Frequently

1 Appetite, decreased     

2

3

4

5

6

7

8

9

10

11

12

13

14

Appetite, increased

Drowsiness / Fatigue

Insomnia

Sexual side effects

Sweating

Tremors

Agitation

Anxiety / Nervousness

Diarrhea

Dry mouth

Indigestion

Nausea

Upset stomach

 

 

 

 

 

 

 

 

 

 

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Anticipated Side Effects and Health Status at Baseline Questionnaire (ASE) Page 1 of 3

ID #:

Instructions: When completing questions #15-26, have the participant answer with respect to the index event.

NO

CARDIOVASCULAR HEALTH STATUS CHANGES

15. Since your cardiac hospitalization on __/__/____ have you had chest pain? ... 

YES

If yes:

15a. Is the chest pain more frequent .............................................................. 

15b. Is the chest pain more severe lately (last 2 weeks)................................. 

15c. Is the chest pain relieved by taking medications (eg nitroglycerin) .......... 

16. Have you had fatigue with minimal exertion or at rest that is new or worse since your cardiac hospitalization? ......................................... 

17. Have you had shortness of breath with normal life activities that is new or worse since your cardiac hospitalization? ............................................. 

18. Have you had shortness of breath when you’re lying down or sudden shortness of breath while sleeping that is new or worse since your cardiac hospitalization? .................................................................................... 

19. Since your cardiac hospitalization, have you been to the ER? ......................... 

20. Since your cardiac hospitalization, have you been admitted to a hospital? ....... 

20a. If Yes , how many times? ________ ( complete a Hospitalization form for each )

Continue to page 3.

N/A

Anticipated Side Effects and Health Status at Baseline Questionnaire (ASE) Page 2 of 3

ID #:

OTHER MEDICAL PROBLEMS

“Since your cardiac hospitalization on __/__/____, have you experienced any of the following?”

NO YES

21. GI problems (e.g., esophageal reflux, diverticulitis) ........................................... 

22. Pneumonia ....................................................................................................... 

23. COPD ............................................................................................................... 

24. Edema .............................................................................................................. 

25. Bleeding ........................................................................................................... 

If Yes, complete a-e:

25a. GI ......................................................................................................... 

25b. Rectal ................................................................................................... 

25c. Vaginal ................................................................................................. 

25d. Other Internal ....................................................................................... 

25e. Nosebleeds .......................................................................................... 

26. Are there any other changes/problems that you have had since your cardiac hospitalization? ................................................................... 

( This should be rare. Complete an Unanticipated Problem Report for each )

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Anticipated Side Effects and Health Status at Baseline Questionnaire (ASE) Page 3 of 3

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