> General notes:

-   Variables not listed here remain in their original form.

-   ID_SOL is a transformed participant ID, with values that range from
    SOL001 through SOL6797.

-   HOSPCODE contains codes for clinic/hospital combinations. Original
    variables CLINIC and HOSPITAL have been dropped.

-   TRIAL contains value P for Prevention Trial participants and value T
    for Treatment Trial participants.

> Definitions:
>
> *Modified variable* A variable that has been dropped or transformed in
> some way.

*Standard date transformation* Subtract date of randomization from
original date, resulting

in the number of days since randomization.

1.  **Data set name: SBF_LAD2**

> **Description: SOLVD Baseline Visit Form (SBF)**
>
> **Form versions: A, B, C**
>
> **Number of observations: 6795**
>
> **Visit range: 3**
>
> **Structure: One observation for each ID_SOL**
>
> **Sort order (unique keys): ID_SOL**

+-----------+-----------------------------+---------------------------+
| #         | # Description               | # Modification/Comment    |
|  Variable |                             |                           |
+-----------+-----------------------------+---------------------------+
| SBF1      | Date form completed         | Standard date             |
|           |                             | transformation            |
+-----------+-----------------------------+---------------------------+
| SBF2Z1    | Participant's last name     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SBF2Z2    | Participant's first name    | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SBF2Z3    | Participant's middle name   | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SBF3Z3A   | \# of most important        | Versions B, C only        |
|           | inclusion criteria not met  |                           |
+-----------+-----------------------------+---------------------------+
| SBF4      | Initials of person          | Dropped, personal         |
|           | completing this form        | information               |
+-----------+-----------------------------+---------------------------+
| SBF4A     | Participant given 2^nd^     | Versions B, C only        |
|           | chance at placebo adherence |                           |
+-----------+-----------------------------+---------------------------+
| SBF9Z3    | How many months ago did     | Top/bottom coding:        |
|           | participant stop smoking    |                           |
|           |                             | Values above 600 recoded  |
|           |                             | to 600.                   |
+-----------+-----------------------------+---------------------------+
| SBF10     | Avg \# of alcoholic         | Top/bottom coding:        |
|           | drinks/wk in last 2 yrs     |                           |
|           |                             | Values above 70 recoded   |
|           |                             | to 70.                    |
+-----------+-----------------------------+---------------------------+
| SBF11Z2   | Date of most recent MI      | Standard date             |
|           |                             | transformation            |
+-----------+-----------------------------+---------------------------+
| SBF13Z1   | Previous cardiac surgery    | Version A only            |
+-----------+-----------------------------+---------------------------+
| SBF13Z2   | Date of most recent cardiac | Standard date             |
|           | surgery (Ver A)             | transformation            |
+-----------+-----------------------------+---------------------------+
| SBF13Z3   | Type of cardiac surgery     | Version A only            |
+-----------+-----------------------------+---------------------------+
| SBF13A    | Previous cardiac            | Versions B, C only        |
|           | surgery/PTCA                |                           |
+-----------+-----------------------------+---------------------------+
| SBF13B    | Date of prev cardiac        | Standard date             |
|           | surgery/PTCA (Ver B,C)      | transformation            |
+-----------+-----------------------------+---------------------------+
| SBF13C    | Type of cardiac             | Versions B, C only        |
|           | surgery/PTCA                |                           |
+-----------+-----------------------------+---------------------------+
| SBF14Z9   | History of atrial           | Version C only            |
|           | fib./flutter or supr.       |                           |
|           | tachyarrythmia              |                           |
+-----------+-----------------------------+---------------------------+
| SBF21Z1   | Currently on vasodilator    | Version-specific          |
|           | (Ver A,B) -- on             |                           |
|           | vasodilator/ACE inhibitor   |                           |
|           | (Ver C)                     |                           |
+-----------+-----------------------------+---------------------------+
| SBF21Z2   | Currently on long-acting    | Versions A, C only        |
|           | nitrate                     |                           |
+-----------+-----------------------------+---------------------------+
| SBF21Z2A  | Currently on oral nitrate   | Renamed to SBF21Z2        |
|           | (Ver B)                     |                           |
+-----------+-----------------------------+---------------------------+
| SBF21Z3   | Currently on other          | Versions A, B only        |
|           | vasodilator                 |                           |
+-----------+-----------------------------+---------------------------+
| SBF21Z3A  | Currently on captopril (Ver | Dropped, count too low    |
|           | C)                          |                           |
|           |                             | 5 Yes, 1635 No            |
+-----------+-----------------------------+---------------------------+
| SBF21Z4   | Currently on enalapril (Ver | Dropped, count too low    |
|           | C)                          |                           |
|           |                             | 2 Yes, 1636 No            |
+-----------+-----------------------------+---------------------------+
| SBF21Z5   | Currently on other ACE      | Dropped, count too low    |
|           | inhibitor (Ver C)           |                           |
|           |                             | 1 Yes, 1637 No            |
+-----------+-----------------------------+---------------------------+
| SBF22Z1   | Currently on other          | Version C only            |
|           | vasodilator                 |                           |
+-----------+-----------------------------+---------------------------+
| SBF26     | Participant using non-ACE   | Version C only            |
|           | vasodilators                |                           |
+-----------+-----------------------------+---------------------------+
| SBF26Z2   | Indication for stopping     | Dropped, long text field  |
|           | non-ACE vasodilators        |                           |
+-----------+-----------------------------+---------------------------+
| SBF27Z1   | EF (ejection fraction)      | Top/bottom coding:        |
|           | percentage                  |                           |
|           |                             | Values below 10 set to    |
|           |                             | 10.                       |
+-----------+-----------------------------+---------------------------+
| SBF27Z2   | Date of obtaining EF %      | Standard date             |
|           |                             | transformation            |
+-----------+-----------------------------+---------------------------+
| SBF28     | Electrocardiogram: normal   | Version A only            |
+-----------+-----------------------------+---------------------------+
| SBF28A    | Atrial fibrillation         | Versions B, C only        |
+-----------+-----------------------------+---------------------------+
| SBF28B    | P wave terminal force in V1 | Top/bottom coding:        |
|           | (Ver B)                     |                           |
|           |                             | Values above 0.50 set to  |
|           |                             | 0.50.                     |
+-----------+-----------------------------+---------------------------+
| SBF28C    | QRS delay \<= 120 ms        | Versions B, C only        |
+-----------+-----------------------------+---------------------------+
| SBF28D    | Amplitude of R wave in V5   | Top/bottom coding:        |
|           | or V6 (Ver B)               |                           |
|           |                             | Values above 4.0 set to   |
|           |                             | 4.0.                      |
+-----------+-----------------------------+---------------------------+
| SBF28E    | Amplitude of R wave in AVL  | Top/bottom coding:        |
|           | (Ver B)                     |                           |
|           |                             | Values above 4.0 set to   |
|           |                             | 4.0.                      |
+-----------+-----------------------------+---------------------------+
| SBF28F    | Amplitude of R wave in II,  | Top/bottom coding:        |
|           | III, or AVF (Ver B)         |                           |
|           |                             | Values above 4.0 set to   |
|           |                             | 4.0.                      |
+-----------+-----------------------------+---------------------------+
| SBF28G    | Amplitude of S wave in V1   | Top/bottom coding:        |
|           | (Ver B)                     |                           |
|           |                             | Values above 4.0 set to   |
|           |                             | 4.0.                      |
+-----------+-----------------------------+---------------------------+
| SBF28H    | Amplitude of S wave in V3   | Top/bottom coding:        |
|           | (Ver B)                     |                           |
|           |                             | Values above 4.0 set to   |
|           |                             | 4.0.                      |
+-----------+-----------------------------+---------------------------+
| SBF28I    | ST segment depression in    | Top/bottom coding:        |
|           | inferior leads of V5 and V6 |                           |
|           | (Ver B)                     | Values above 0.30 set to  |
|           |                             | 0.30.                     |
+-----------+-----------------------------+---------------------------+
| SBF28J    | Left ventricular            | Version C only            |
|           | hypertrophy                 |                           |
+-----------+-----------------------------+---------------------------+
| SBF28K    | Q wave MI                   | Version C only            |
+-----------+-----------------------------+---------------------------+
| SBF28L    | Location of MI              | Version C only            |
+-----------+-----------------------------+---------------------------+
| SBF29     | Atrial fibrillation/flutter | Version A only            |
+-----------+-----------------------------+---------------------------+
| SBF30     | QRS delay \>= 120 ms        | Version A only            |
+-----------+-----------------------------+---------------------------+
| SBF31Z1   | Left ventricular            | Version A only            |
|           | hypertrophy                 |                           |
+-----------+-----------------------------+---------------------------+
| SBF31Z2   | P wave                      | Version A only            |
+-----------+-----------------------------+---------------------------+
| SBF31Z3   | Amplitude V3 in S & R wave  | Version A only            |
+-----------+-----------------------------+---------------------------+
| SBF31Z4   | ST segment                  | Version A only            |
+-----------+-----------------------------+---------------------------+
| SBF32Z1   | Cardiac-thoracic ratio      | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values above 0.70 set to  |
|           |                             | 0.70.                     |
+-----------+-----------------------------+---------------------------+
| SBF33Z1   | Weight (to nearest lb)      | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 100 set to   |
|           |                             | 100.                      |
|           |                             |                           |
|           |                             | Values above 300 set to   |
|           |                             | 300.                      |
+-----------+-----------------------------+---------------------------+
| SBF33Z2   | Weight (to nearest kg)      | Top/bottom coding:        |
|           |                             |                           |
|           | Note: When weight is        | Values below 45 set to    |
|           | available in both lb and    | 45.                       |
|           | kg, the value is lb is      |                           |
|           | generally more trustworthy. | Values above 136 set to   |
|           |                             | 136.                      |
+-----------+-----------------------------+---------------------------+
| SBF34     | Heart rate (sitting)        | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 45 set to    |
|           |                             | 45.                       |
|           |                             |                           |
|           |                             | Values above 120 set to   |
|           |                             | 120.                      |
+-----------+-----------------------------+---------------------------+
| SBF35Z1   | Systolic BP (sitting)       | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 85 set to    |
|           |                             | 85.                       |
|           |                             |                           |
|           |                             | Values above 180 set to   |
|           |                             | 180.                      |
+-----------+-----------------------------+---------------------------+
| SBF35Z2   | Diastolic BP (sitting)      | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 50 set to    |
|           |                             | 50.                       |
|           |                             |                           |
|           |                             | Values above 110 set to   |
|           |                             | 110.                      |
+-----------+-----------------------------+---------------------------+
| SBF36Z4   | S3 gallop (Ver A,B) -- S3   | Version-specific          |
|           | (Ver C)                     |                           |
+-----------+-----------------------------+---------------------------+
| SBF37Z2   | Description of primary      | Dropped, long text field  |
|           | cause of CHF if "other"     |                           |
+-----------+-----------------------------+---------------------------+
| SBF38A    | Participant still eligible  | Versions B, C only        |
|           | for randomization           |                           |
+-----------+-----------------------------+---------------------------+
| SBF38B    | Reason for ineligibility    | Versions B, C only        |
|           | for randomization           |                           |
+-----------+-----------------------------+---------------------------+
| SBF39     | Trial: Prevention/Treatment | Dropped, use the variable |
|           |                             | TRIAL                     |
+-----------+-----------------------------+---------------------------+
| SBF41     | Randomization number        | Dropped, NHLBI guidelines |
+-----------+-----------------------------+---------------------------+
| SBF43     | Date of next scheduled      | Dropped, available in     |
|           | visit                       | follow-up form files      |
+-----------+-----------------------------+---------------------------+

2.  **Data set name: SDC_LAD2**

> **Description: SOLVD Alteration in Study Drug Dosage Form (SDC)**
>
> **Form versions: A, B**
>
> **Number of observations: 8329**
>
> **Visit range: 3-19**
>
> **Structure: Multiple observations for each ID_SOL and possibly for
> each ID_SOL and VISIT**
>
> **Sort order (unique keys): ID_SOL VISIT VISSEQ**

+-----------+-----------------------------+---------------------------+
| #         | #                           | #                         |
|           |                             |                           |
| #         | # Description               | # Modification/Comment    |
|  Variable |                             |                           |
+-----------+-----------------------------+---------------------------+
| SDC1      | Date form completed         | Standard date             |
|           |                             | transformation            |
+-----------+-----------------------------+---------------------------+
| SDC2Z1    | Participant's last name     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SDC2Z2    | Participant's first name    | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SDC2Z3    | Participant's middle name   | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SDC3      | Initials of person          | Dropped, personal         |
|           | completing this form        | information               |
+-----------+-----------------------------+---------------------------+
| SDC5Z1    | Is more study drug needed   | Version B only            |
|           | at the new, altered dose?   |                           |
+-----------+-----------------------------+---------------------------+
| SDC6      | Type of dose change:        | Version-specific          |
|           | Increase/decrease (Ver A),  |                           |
|           | Increase/decrease/stopping  |                           |
|           | (Ver B)                     |                           |
+-----------+-----------------------------+---------------------------+
| SDC7Z3S   | Increasing dose: Specify    | Dropped, long text field  |
|           | other reason                |                           |
+-----------+-----------------------------+---------------------------+
| SDC8Z3    | Decreasing dose, due to     | Version-specific          |
|           | taste abnormalities (Ver A) |                           |
|           | / Altered taste (Ver B)     |                           |
+-----------+-----------------------------+---------------------------+
| SDC8Z4A   | Decreasing dose, due to     | Version B only            |
|           | dizziness/fainting          |                           |
+-----------+-----------------------------+---------------------------+
| SDC8Z4B   | Decreasing dose, due to     | Version B only            |
|           | fatigue                     |                           |
+-----------+-----------------------------+---------------------------+
| SDC8Z4C   | Decreasing dose, due to     | Version B only            |
|           | nausea                      |                           |
+-----------+-----------------------------+---------------------------+
| SDC8Z4D   | Decreasing dose, due to     | Dropped, collapsed into   |
|           | angioneurotic edema (Ver B) | SDC8Z6X                   |
+-----------+-----------------------------+---------------------------+
| SDC8Z4E   | Decreasing dose, due to     | Version B only            |
|           | cough                       |                           |
+-----------+-----------------------------+---------------------------+
| SDC8Z6    | Decreasing dose, due to     | Dropped, see SDC8Z6X      |
|           | other side effect           |                           |
+-----------+-----------------------------+---------------------------+
| SDC8Z6X   | Decreasing dose, due to     | Combination of original   |
|           | angioneurotic edema or      | SDC8Z6 and SDC8Z4D        |
|           | other side effect           |                           |
+-----------+-----------------------------+---------------------------+
| SDC8Z6S   | Decreasing dose: Specify    | Coded into side effect    |
|           | other side effect           | categories summarized     |
|           |                             | below this table.         |
+-----------+-----------------------------+---------------------------+
| SDC10Z2   | Specify cardiac surgery     | Dropped, long text field  |
|           | other than transplant       |                           |
+-----------+-----------------------------+---------------------------+
| SDC16S    | Specify other reason        | Dropped, long text field  |
|           |                             | -- About 100 entries,     |
|           |                             | only, contain useful      |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+

> **Side effect and Reason categories used for SDC8Z6S:**
>
> 1 = Side effects: Symptomatic hypotension
>
> 2 = Side effects: Taste / smell disturbance
>
> 3 = Side effects: Skin Rash/pruritis/flushing, Itching/ urticaria/
> hives/gingivitis/ incr.
>
> eosinophils
>
> 4 = Side effects: Dizziness/Fainting (Light Headed, near syncope),
> Syncope, Ataxia,
>
> vertigo, Hypotension
>
> 5 = Side effects: Fatigue, drowsiness, lethargy
>
> 6 = Side effects: Nausea/indigestion
>
> 7 = Side effects: Possible angioedema
>
> 8 = Side effects: Cough
>
> 9 = Side effects: Azotemia (incr. creatinine or BUN), renal failure,
> Hyperkalemia,
>
> Proteinuria
>
> 10 = Side effects: Leg pain/weakness/claudication/PVD, Raynaud\'s
>
> 11 = Side effects: Chest pain/angina, worsening or unstable angina
>
> 12 = Side effects: Diarrhea, Constipation, Stomach / abdominal pain,
> Loss of appetite/
>
> weight loss, anorexia
>
> 13 = Side effects: Headache
>
> 14 = Side effects: Heart irregularity-arrhythmia
>
> 15 = Side effects: Impotence, sexual dysfunction, decreased libido
>
> 16 = Side effects: CNS symptoms: Sleep disturbance,
> Numbness/tingling/parasthesia /
>
> shingles, Ear problem/tinitus/hearing loss, Irritable /nervous
> /anxiety /tension /
>
> personality chg., Backache, Depression, Tremor
>
> 17 = Side effects: Sweating/diaphoresis
>
> 18 = Side effects: Dryness in mouth/thirst
>
> 19 = Side effects: Arthritis, carpal tunnel
>
> 20 = Side effects: Stroke/TIA, subdural hematoma, CVA
>
> 21 = Side effects: Hyponatremia
>
> 22 = Side effects: Easy bruising, decreased platelets, ecchymosis
>
> 23 = Other side effects: Blurred vision, Forgetfulness, confusion,
> slow thinking, memory
>
> dec., Vision problem/eye aches, Leukocytosis,
> Chills/cold,flu,fever/nasal
>
> discharge/mucus prod./sore throat, Leukopenia, Nose bleed, epistaxsis,
>
> Hemoptysis, Hyperglycemia, increased glucose, Hair loss, alopecia,
> Miscellaneous
>
> GI symptoms / bowel obstruct./ bile duct obstruction/ esophageal
> tumor, gastric
>
> ulcer bleeding, Musculoskeletal problems, , aching all over,
> Menopausal
>
> symptoms, vaginal bleeding, Hypertension, Hypothyroidism, Seizures,
>
> Gynecomastia, tender breasts, Pleuritic pain, wheezing, pneumonia,
> pulmon.
>
> Embolus, Hypokalemia, Other miscellaneous
>
> 24 = MI/ R/O MI (myocardial infarction)
>
> 25 = Cardiac surgery
>
> 26 = cardiac transplant, awaiting heart transplant
>
> 27 = Noncardiac surgery
>
> 28 = CHF Symptoms (SOB), edema, congestion, PND, Taking
> Captopril/Vasotec/Other
>
> ACE-I
>
> 29 = SOLVD MD decreased dose/SOLVD RN
>
> 30 = Requested by participant
>
> 31 = Other reasons: Cancer; No show, non-compliant, participant
> stopped on own, ran
>
> out of meds, drug not available, moved out of country, dispensing
> error, house
>
> staff error, requested by wife, self unblinding, dosing error/ too
> sick to come,
>
> Hospitalization; Increased Triglyceride, asculitis, arteritis,
> phlebitis
>
> Note: categories 7, 10, 11, 17-22, and text descriptions that
> indicated "Urinary problem,
>
> Nocturia, urinary freq, L. flank pain, hematuria" were collapsed into
> category 23 (Other side effects), due to sparseness of counts in each
> category. Categories 24-27 and 29-30 were collapsed into category 31
> (Other reasons), due to sparseness of counts in each category.

3.  **Data set name: SEF_LAD2**

> **Description: SOLVD Eligibility Visit Form (SEF)**
>
> **Form versions: A, B, C**
>
> **Number of observations: 6797**
>
> **Visit range: 1**
>
> **Structure: One observation for each ID_SOL**
>
> **Sort order (unique keys): ID_SOL**

+-----------+-----------------------------+---------------------------+
| #         | # Description               | **Modification/Comment**  |
|  Variable |                             |                           |
+-----------+-----------------------------+---------------------------+
| SEF_AGE   | Participant's age at        | Calculated as             |
|           | eligibility visit           |                           |
|           |                             | floor(date form completed |
|           |                             | --                        |
|           |                             |                           |
|           |                             | date of birth, or         |
|           |                             |                           |
|           |                             | sef1-sef11)/365.25        |
|           |                             |                           |
|           |                             | Hard-coded in 11 cases.   |
|           |                             |                           |
|           |                             | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 27 recoded   |
|           |                             | to 27.                    |
+-----------+-----------------------------+---------------------------+
| SEF1      | Date form completed         | Standard date             |
|           |                             | transformation            |
+-----------+-----------------------------+---------------------------+
| SEF2Z1    | Participant's last name     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF2Z2    | Participant's first name    | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF2Z3    | Participant's middle name   | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF2Z4    | Participant's third name    | Dropped, personal         |
|           | (maiden, initial, etc.)     | information               |
+-----------+-----------------------------+---------------------------+
| SEF3Z1A   | Street address -- line #1   | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF3Z1B   | Street address -- line #2   | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF3Z2    | City                        | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF3Z3    | State/province              | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF3Z4    | Country                     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF3Z5    | Zip code/Canadian or        | Dropped, personal         |
|           | European postal code        | information               |
+-----------+-----------------------------+---------------------------+
| SEF3Z5A   | Zip code/Canadian or        | # Drop                    |
|           | European postal code --     | ped, personal information |
|           | part A (Ver C)              |                           |
+-----------+-----------------------------+---------------------------+
| SEF3Z5B   | Zip code/Canadian or        | # Drop                    |
|           | European postal code --     | ped, personal information |
|           | part B (Ver C)              |                           |
+-----------+-----------------------------+---------------------------+
| SEF4      | Telephone number (home)     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF5Z1    | Hospital: Name              | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF5Z2A   | Hospital: Street address -- | Dropped, personal         |
|           | line #1                     | information               |
+-----------+-----------------------------+---------------------------+
| SEF5Z2B   | Hospital: Street address -- | Dropped, personal         |
|           | line #2                     | information               |
+-----------+-----------------------------+---------------------------+
| SEF5Z3    | Hospital: City              | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF5Z4    | Hospital: State/province    | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF5Z5    | Hospital: Country           | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF5Z6    | Hospital: Zip code/Canadian | Dropped, personal         |
|           | or European postal code     | information               |
+-----------+-----------------------------+---------------------------+
| SEF5Z7    | Participant hospital ID     | Dropped, personal         |
|           | number                      | information               |
+-----------+-----------------------------+---------------------------+
| SEF6Z1    | Private physician: Last     | Dropped, personal         |
|           | name                        | information               |
+-----------+-----------------------------+---------------------------+
| SEF6Z2    | Private physician: First    | Dropped, personal         |
|           | name                        | information               |
+-----------+-----------------------------+---------------------------+
| SEF6Z3A   | Private physician: Street   | Dropped, personal         |
|           | address -- line #1          | information               |
+-----------+-----------------------------+---------------------------+
| SEF6Z3B   | Private physician: Street   | Dropped, personal         |
|           | address -- line #2          | information               |
+-----------+-----------------------------+---------------------------+
| SEF6Z4    | Private physician: City     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF6Z5    | Private physician:          | Dropped, personal         |
|           | State/province              | information               |
+-----------+-----------------------------+---------------------------+
| SEF6Z6    | Private physician: Country  | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF6Z7    | Private physician: Zip      | Dropped, personal         |
|           | code/Canadian or European   | information               |
|           | postal code                 |                           |
+-----------+-----------------------------+---------------------------+
| SEF6Z8    | Private physician:          | Dropped, personal         |
|           | Telephone number            | information               |
+-----------+-----------------------------+---------------------------+
| SEF7Z1    | Relative/friend: Last name  | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF7Z2    | Relative/friend: First name | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF7Z3    | Relative/friend:            | Dropped, personal         |
|           | Relationship                | information               |
+-----------+-----------------------------+---------------------------+
| SEF7Z4A   | Relative/friend: Street     | Dropped, personal         |
|           | address -- line #1          | information               |
+-----------+-----------------------------+---------------------------+
| SEF7Z4B   | Relative/friend: Street     | Dropped, personal         |
|           | address -- line #2          | information               |
+-----------+-----------------------------+---------------------------+
| SEF7Z5    | Relative/friend: City       | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF7Z6    | Relative/friend:            | Dropped, personal         |
|           | State/province              | information               |
+-----------+-----------------------------+---------------------------+
| SEF7Z7    | Relative/friend: Country    | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF7Z8    | Relative/friend: Zip        | Dropped, personal         |
|           | code/Canadian or European   | information               |
|           | postal code                 |                           |
+-----------+-----------------------------+---------------------------+
| SEF7Z9    | Relative/friend: Telephone  | Dropped, personal         |
|           | number --                   | information               |
+-----------+-----------------------------+---------------------------+
| SEF8Z1    | Employer: Name or Status    | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF8Z2    | Participant's Job title     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF8Z3A   | Employer: Street address -- | Dropped, personal         |
|           | line \#                     | information               |
+-----------+-----------------------------+---------------------------+
| SEF8Z3B   | Employer: Street address -- | Dropped, personal         |
|           | line #2                     | information               |
+-----------+-----------------------------+---------------------------+
| SEF8Z4    | Employer: City              | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF8Z5    | Employer: State/province    | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF8Z6    | Employer: Country           | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF8Z7    | Employer: Zip code/Canadian | Dropped, personal         |
|           | or European postal code     | information               |
+-----------+-----------------------------+---------------------------+
| SEF8Z8    | Employer: Telephone number  | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF10     | Ethnic identity (1-6 =      | Collapsed into W=White,   |
|           | Am.Indian, Asian, Black,    | B=Black, O=Other, where O |
|           | Caucasian, Hispanic, Other) | includes Am. Indian,      |
|           |                             | Asian, Hispanic, and      |
|           |                             | Other                     |
+-----------+-----------------------------+---------------------------+
| SEF11     | Date of birth               | Dropped after use in      |
|           |                             | SEF_AGE calculation       |
+-----------+-----------------------------+---------------------------+
| SEF11Z1   | Marital status (1-4 =       | Collapsed into M          |
|           | married,                    | (married), D_S            |
|           | divorced/separated,         | (divorced/separated), W_N |
|           | widowed, never married)     | (widowed or never         |
|           | (Ver C)                     | married)                  |
+-----------+-----------------------------+---------------------------+
| SEF12     | Social security number      | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SEF13Z1   | Qualifying ejection         | Top/bottom coding:        |
|           | fraction (%)                |                           |
|           |                             | Values below 10 recoded   |
|           |                             | to 10.                    |
|           |                             |                           |
|           |                             | Values above 35 recoded   |
|           |                             | to 35.                    |
+-----------+-----------------------------+---------------------------+
| SEF13Z2   | Date of ejection fraction   | Standard date             |
|           | measurement                 | transformation            |
+-----------+-----------------------------+---------------------------+
| SEF14Z1   | Most recent ejection        | Dropped, count too low    |
|           | fraction (%)                |                           |
+-----------+-----------------------------+---------------------------+
| SEF14Z2   | Date of most recent EF      | Dropped, see SEF14Z1      |
|           | measurement                 |                           |
+-----------+-----------------------------+---------------------------+
| # SEF     | # Exclusion criteria        | Dropped, not relevant for |
| 15 (all v |                             | randomized participants   |
| ariables) |                             |                           |
+-----------+-----------------------------+---------------------------+
| SEF16     | Initials of person          | Dropped, personal         |
|           | completing this form        | information               |
+-----------+-----------------------------+---------------------------+
| SEF18Z1   | Systolic blood pressure --  | Top/bottom coding:        |
|           | supine (mm Hg)              |                           |
|           |                             | Values below 85 recoded   |
|           |                             | to 85.                    |
|           |                             |                           |
|           |                             | Values above 180 recoded  |
|           |                             | to 180.                   |
+-----------+-----------------------------+---------------------------+
| SEF18Z2   | Diastolic blood pressure -- | Top/bottom coding:        |
|           | supine (mm Hg)              |                           |
|           |                             | Values below 50 recoded   |
|           |                             | to 50.                    |
|           |                             |                           |
|           |                             | Values above 110 recoded  |
|           |                             | to 110.                   |
+-----------+-----------------------------+---------------------------+
| SEF19Z1   | Systolic blood pressure --  | Top/bottom coding:        |
|           | sitting (mm Hg)             |                           |
|           |                             | Values below 90 recoded   |
|           |                             | to 90.                    |
|           |                             |                           |
|           |                             | Values above 180 recoded  |
|           |                             | to 180.                   |
+-----------+-----------------------------+---------------------------+
| SEF19Z2   | Diastolic blood pressure -- | Top/bottom coding:        |
|           | sitting (mm Hg)             |                           |
|           |                             | Values below 50 recoded   |
|           |                             | to 50. Values above 110   |
|           |                             | recoded to 110.           |
+-----------+-----------------------------+---------------------------+
| SEF20Z1   | Heart rate -- supine (beats | Top/bottom coding:        |
|           | per minute)                 |                           |
|           |                             | Values below 47 recoded   |
|           |                             | to 47.                    |
|           |                             |                           |
|           |                             | Values above 120 recoded  |
|           |                             | to 120.                   |
+-----------+-----------------------------+---------------------------+
| SEF20Z2   | Heart rate -- sitting       | Top/bottom coding:        |
|           | (beats per minute)          |                           |
|           |                             | Values below 47 recoded   |
|           |                             | to 47.                    |
|           |                             |                           |
|           |                             | Values above 120 recoded  |
|           |                             | to 120.                   |
+-----------+-----------------------------+---------------------------+
| SEF21     | Hematocrit (HCT) (%)        | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 28 recoded   |
|           |                             | to 28.                    |
|           |                             |                           |
|           |                             | Values above 55 recoded   |
|           |                             | to 55.                    |
+-----------+-----------------------------+---------------------------+
| SEF22Z1   | Total white bood count (WBC | Top/bottom coding:        |
|           | x 1000)                     |                           |
|           |                             | Values below 3 recoded to |
|           |                             | 3.                        |
|           |                             |                           |
|           |                             | Values above 16 recoded   |
|           |                             | to 16.                    |
+-----------+-----------------------------+---------------------------+
| SEF22Z2   | Percent neutrophils         | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 26 recoded   |
|           |                             | to 26.                    |
|           |                             |                           |
|           |                             | Values above 86 recoded   |
|           |                             | to 86.                    |
+-----------+-----------------------------+---------------------------+
| SEF22Z3   | Percent lymphocytes         | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 5 recoded to |
|           |                             | 5.                        |
|           |                             |                           |
|           |                             | Values above 60 recoded   |
|           |                             | to 60.                    |
+-----------+-----------------------------+---------------------------+
| SEF23     | Sodium (Na) (meq/l)         | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 129 recoded  |
|           |                             | to 129.                   |
|           |                             |                           |
|           |                             | Values above 149 recoded  |
|           |                             | to 149.                   |
+-----------+-----------------------------+---------------------------+
| SEF24     | Potassium (K) (meq/l)       | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 3.1 recoded  |
|           |                             | to 3.1.                   |
|           |                             |                           |
|           |                             | Values above 5.9 recoded  |
|           |                             | to 5.9.                   |
+-----------+-----------------------------+---------------------------+
| SEF25     | Blood urea nitrogen (BUN)   | Top/bottom coding:        |
|           | (mg/dl)                     |                           |
|           |                             | Values below 5 recoded to |
|           |                             | 5.                        |
|           |                             |                           |
|           |                             | Values above 49 recoded   |
|           |                             | to 49.                    |
+-----------+-----------------------------+---------------------------+
| SEF26     | Creatinine (mg/dl)          | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 0.5 recoded  |
|           |                             | to 0.5.                   |
|           |                             |                           |
|           |                             | Values above 2.4 recoded  |
|           |                             | to 2.4.                   |
+-----------+-----------------------------+---------------------------+
| SEF27     | Proteinurea (0-4) (1="+")   | Collapsed into C0 (0), C1 |
|           | (Ver A)                     | (1), C2 (2), C3_4 (3, 4). |
+-----------+-----------------------------+---------------------------+
| SEF27A    | Proteinurea (0-4) (1="trace | Collapsed into C0 (0), C1 |
|           | or +") (Ver B,C)            | (1), C2 (2), C3_4 (3, 4). |
+-----------+-----------------------------+---------------------------+
| SEF28Z1   | Participant taking          | Version A only            |
|           | isosorbide med?             |                           |
+-----------+-----------------------------+---------------------------+
| SEF28Z2   | Daily dose (mg) of          | Dropped, dropped all      |
|           | isosorbide med (Ver A)      | dosages for sparseness of |
|           |                             | data                      |
+-----------+-----------------------------+---------------------------+
| SEF28AA   | Participant taking          | Version C only            |
|           | vasodilators?               |                           |
+-----------+-----------------------------+---------------------------+
| SEF28A    | Participant taking oral     | Version-specific          |
|           | nitrate? (Ver B), long      |                           |
|           | acting nitrate? (Ver C)     |                           |
+-----------+-----------------------------+---------------------------+
| SEF28B    | Participant taking          | Versions B, C only        |
|           | isosorbide med?             |                           |
+-----------+-----------------------------+---------------------------+
| SEF28C    | Participant stopping use of | Dropped, count too low    |
|           | oral nitrate? (Ver B), long |                           |
|           | acting nitrate? (Ver C)     |                           |
+-----------+-----------------------------+---------------------------+
| SEF28D    | Indication for continuing   | Dropped, long text field  |
|           | use of oral nitrate (Ver    |                           |
|           | B), long acting nitrate     |                           |
|           | (Ver C)                     |                           |
+-----------+-----------------------------+---------------------------+
| SEF29Z1   | Participant taking any      | Version A                 |
|           | vasodilator other than      |                           |
|           | isosorbide?                 |                           |
+-----------+-----------------------------+---------------------------+
| SEF29Z2B  | Total daily dose of         | Dropped, count too low    |
|           | prazosin (mg) (Ver A)       |                           |
+-----------+-----------------------------+---------------------------+
| SEF29ZB2  | Will prazosin be            | Dropped, count too low    |
|           | discontinued? (Ver B,C)     |                           |
+-----------+-----------------------------+---------------------------+
| SEF29Z2C  | Indication for continuing   | Dropped, long text field  |
|           | prazosin (Ver B,C)          |                           |
+-----------+-----------------------------+---------------------------+
| SEF29Z3B  | Total daily dose of         | Dropped, count too low    |
|           | hydralazine (mg) (Ver A)    |                           |
+-----------+-----------------------------+---------------------------+
| SEF29ZB3  | Will hydralazine be         | Dropped, count too low    |
|           | discontinued? (Ver B,C)     |                           |
+-----------+-----------------------------+---------------------------+
| SEF29Z3C  | Indication for continuing   | Dropped, long text field  |
|           | hydralazine (Ver B,C)       |                           |
+-----------+-----------------------------+---------------------------+
| SEF29Z4A  | Participant taking          | Version-specific          |
|           | nifedipine? (Ver A) calcium |                           |
|           | channel blocker? (Ver B,C)  |                           |
+-----------+-----------------------------+---------------------------+
| SEF29Z4B  | Total daily dose of         | Dropped, count too low    |
|           | nifedipine (mg) (Ver A)     |                           |
+-----------+-----------------------------+---------------------------+
| SEF29ZB4  | Will calcium channel        | Dropped, count too low    |
|           | blocker be discontinued?    |                           |
|           | (Ver B,C)                   |                           |
+-----------+-----------------------------+---------------------------+
| SEF29Z4C  | Indication for continuing   | Dropped, long text field  |
|           | calcium channel blocker     |                           |
|           | (Ver B,C)                   |                           |
+-----------+-----------------------------+---------------------------+
| SEF29Z5   | Participant taking other    | Version A only            |
|           | vasodilator?                |                           |
+-----------+-----------------------------+---------------------------+
| SEF29Z5A  | Participant taking other    | Version-specific          |
|           | vasodilator (other than     |                           |
|           | oral nitrate)? (Ver B),     |                           |
|           | (other than long acting     |                           |
|           | nitrate)? (Ver C)           |                           |
+-----------+-----------------------------+---------------------------+
| SEF29Z5B  | Will other vasodilator      | Dropped, count too low    |
|           | (other than oral nitrate -  |                           |
|           | Ver B) (other than long     |                           |
|           | acting nitrate -- Ver C) be |                           |
|           | discontinued?               |                           |
+-----------+-----------------------------+---------------------------+
| SEF29Z5C  | Indication for continuing   | Dropped, long text field  |
|           | other vasodilator (other    |                           |
|           | than oral nitrate) (Ver B)  |                           |
|           | (other than long acting     |                           |
|           | nitrate) (Ver C)            |                           |
+-----------+-----------------------------+---------------------------+
| SEF30Z1   | Participant discontinuing   | Dropped, count too low    |
|           | all non-ACE vasodilators?   |                           |
|           | (Ver A)                     |                           |
+-----------+-----------------------------+---------------------------+
| SEF30Z2   | Indication for continuing   | Dropped, long text field  |
|           | non-ACE vasodilators (Ver   |                           |
|           | A)                          |                           |
+-----------+-----------------------------+---------------------------+
| SEF32Z1   | For which trial is          | Version C only            |
|           | participant eligible? (P,T) |                           |
+-----------+-----------------------------+---------------------------+
| SEF33Z1   | Participant not taking      | Version A only            |
|           | hydralazine or isosorbide   |                           |
|           | medication?                 |                           |
+-----------+-----------------------------+---------------------------+
| SEF33Z1A  | Participant taking          | Versions B, C only        |
|           | hydralazine or isosorbide   |                           |
|           | medication?                 |                           |
+-----------+-----------------------------+---------------------------+

4.  **Data set name: SEP_LAD2**

> **Description: SOLVD Endpoints (Derived) File**
>
> **Form versions: Not applicable**
>
> **Number of observations: 6797**
>
> **Visit range: Not applicable**
>
> **Structure: One observation for each ID_SOL**
>
> **Sort order (unique keys): ID_SOL**

+-----------+----------------------------------------------------------+
| #         | # Description                                            |
|  Variable |                                                          |
+-----------+----------------------------------------------------------+
| DDATE     | For deceased participants, number of days from           |
|           | randomization to date of death                           |
+-----------+----------------------------------------------------------+
| EP1       | All-cause mortality, indicated by the presence of form   |
|           | SFN (the SOLVD First Notification of Death form) or form |
|           | SFD (the SOLVD Final Designation of Death form). There   |
|           | are 1,609 participants who have EP1=1. Use the variable  |
|           | FUTIME, described below, for follow-up time for this     |
|           | event.                                                   |
+-----------+----------------------------------------------------------+
| EP2       | All-cause mortality, indicated by the presence of form   |
|           | SFD, the SOLVD Final Designation of Death form. There    |
|           | are 1,599 participants who have EP2=1. Use the variable  |
|           | FUTIME, described below, for follow-up time for this     |
|           | event.                                                   |
+-----------+----------------------------------------------------------+
| EP3       | Cardiovascular death, indicated by the response 'C' to   |
|           | item SFD5 of the SOLVD Final Designation of Death form.  |
|           | There are 1,413 participants who have EP3=1. Use the     |
|           | variable FUTIME, described below, for follow-up time for |
|           | this event.                                              |
+-----------+----------------------------------------------------------+
| EP4       | Cardiac death, indicated by the response 'C' to item     |
|           | SFD6Z1 (for versions A, B) or SFD6Z1A (for version C) of |
|           | the SOLVD Final Designation of Death form. There are     |
|           | 1,326 participants who have EP4=1. Use the variable      |
|           | FUTIME, described below, for follow-up time for this     |
|           | event.                                                   |
+-----------+----------------------------------------------------------+
| EP5       | Cardiac death, with the most likely terminal event being |
|           | probable arrhythmia [without]{.underline} preceding      |
|           | worsening symptoms of CHF \-- indicated by the response  |
|           | '1' to item SFD6Z2 of the SOLVD Final Designation of     |
|           | Death form. There are 424 participants who have EP5=1.   |
|           | Use the variable FUTIME, described below, for follow-up  |
|           | time for this event.                                     |
+-----------+----------------------------------------------------------+
| EP6       | Cardiac death, with the most likely terminal event being |
|           | probable arrhythmia [with]{.underline} some preceding    |
|           | worsening symptoms of CHF \-- indicated by the response  |
|           | '2' to item SFD6Z2 of the SOLVD Final Designation of     |
|           | Death form. There are 193 participants who have EP6=1.   |
|           | Use the variable FUTIME, described below, for follow-up  |
|           | time for this event.                                     |
+-----------+----------------------------------------------------------+
| EP7       | Cardiac death, with the most likely terminal event being |
|           | primarily related to pump failure, even if terminal      |
|           | event was an arrhythmia \-- indicated by the response    |
|           | '3' to item SFD6Z2 of the SOLVD Final Designation of     |
|           | Death form. There are 469 participants who have EP7=1.   |
|           | Use the variable FUTIME, described below, for follow-up  |
|           | time for this event.                                     |
+-----------+----------------------------------------------------------+
| EP8       | Cardiac death, with the most likely terminal event being |
|           | probable myocardial infarction \-- indicated by the      |
|           | response '5' to item SFD6Z2 of the SOLVD Final           |
|           | Designation of Death form. There are 205 participants    |
|           | who have EP8=1. Use the variable FUTIME, described       |
|           | below, for follow-up time for this event.                |
+-----------+----------------------------------------------------------+
| EP9       | Cardiac death, with the most likely terminal event being |
|           | "Other" \-- indicated by the response '4' to item SFD6Z2 |
|           | of the SOLVD Final Designation of Death form. There are  |
|           | 35 participants who have EP9=1. Use the variable FUTIME, |
|           | described below, for follow-up time for this event.      |
+-----------+----------------------------------------------------------+
| EP10      | Death due to stroke, indicated by the response 'S' to    |
|           | item SFD6Z1 (for versions A, B) or SFD6Z1A (for version  |
|           | C) of the SOLVD Final Designation of Death form. There   |
|           | are 45 participants who have EP10=1. Use the variable    |
|           | FUTIME, described below, for follow-up time for this     |
|           | event.                                                   |
+-----------+----------------------------------------------------------+
| EP11_12   | Death due to pulmonary embolism or other vascular or     |
|           | unknown cardiovascular cause, indicated by the re-coded  |
|           | response 'X' to item SFD6Z1A of the SOLVD Final          |
|           | Designation of Death form. There are 42 participants who |
|           | have EP11_12=1. Use the variable FUTIME, described       |
|           | below, for follow-up time for this event.                |
+-----------+----------------------------------------------------------+
| EP13      | Non-cardiovascular death, indicated by the response 'N'  |
|           | to item SFD5 of the SOLVD Final Designation of Death     |
|           | form. There are 186 participants who have EP13=1. Use    |
|           | the variable FUTIME, described below, for follow-up time |
|           | for this event.                                          |
+-----------+----------------------------------------------------------+
| EP14      | Non-cardiovascular death: Type of death is a secondary   |
|           | complication of heart failure \-- indicated by the       |
|           | response '1' to item SFD7Z1 of the SOLVD Final           |
|           | Designation of Death form. There are 30 participants who |
|           | have EP14=1. Use the variable FUTIME, described below,   |
|           | for follow-up time for this event.                       |
+-----------+----------------------------------------------------------+
| EP15      | Non-cardiovascular death: Type of death is a primary     |
|           | event independent of heart failure \-- indicated by the  |
|           | response '2' to item SFD7Z1 of the SOLVD Final           |
|           | Designation of Death form. There are 123 participants    |
|           | who have EP15=1. Use the variable FUTIME, described      |
|           | below, for follow-up time for this event.                |
+-----------+----------------------------------------------------------+
| EP16      | Non-cardiovascular death due to cancer \-- indicated by  |
|           | the response 'Y' to item SFD7Z2 of the SOLVD Final       |
|           | Designation of Death form. There are 84 participants who |
|           | have EP16=1. Use the variable FUTIME, described below,   |
|           | for follow-up time for this event.                       |
+-----------+----------------------------------------------------------+
| EP17      | Non-cardiovascular non-cancer death \-- indicated by the |
|           | response 'N' to item SFD7Z2 of the SOLVD Final           |
|           | Designation of Death form. There are 40 participants who |
|           | have EP17=1. Use the variable FUTIME, described below,   |
|           | for follow-up time for this event.                       |
+-----------+----------------------------------------------------------+
| EP18      | Non-cardiovascular death: Type of death is neither a     |
|           | secondary complication of heart failure nor a primary    |
|           | event independent of heart failure \-- indicated by the  |
|           | response '3' to item SFD7Z1 of the SOLVD Final           |
|           | Designation of Death form. There are 33 participants who |
|           | have EP18=1. Use the variable FUTIME, described below,   |
|           | for follow-up time for this event.                       |
+-----------+----------------------------------------------------------+
| EPA       | This indicator has the value of 1 when either EPY=1 or   |
|           | EPZ=1 (see below), and 0 otherwise. There are 2,472      |
|           | participants who have EPA=1.Use the variable EPATIME,    |
|           | described below, for follow-up time for this event.      |
+-----------+----------------------------------------------------------+
| EPATIME   | Follow-up time in days for endpoint EPA (which is 1      |
|           | (Yes) if EPY=1 or EPZ=1). It is the minimum of EPYTIME   |
|           | and EPZTIME (see below).                                 |
+-----------+----------------------------------------------------------+
| EPB       | This indicator has the value of 1 when either EPA=1 (see |
|           | above) or EP1=1                                          |
|           |                                                          |
|           | (all-cause mortality -- see earlier), and 0 otherwise.   |
|           | There are 3,225 participants who have EPB=1. Use the     |
|           | variable EPBTIME, described below, for follow-up time    |
|           | for this event.                                          |
+-----------+----------------------------------------------------------+
| EPBTIME   | Follow-up time in days for endpoint EPB (which is 1      |
|           | (Yes) if EPA=1 or EP1=1). It is the minimum of EPATIME   |
|           | (see above) and FUTIME (see below).                      |
+-----------+----------------------------------------------------------+
| EPT       | This 0/1 indicator has the value of 1 for participants   |
|           | who have been randomized into the Prevention Trial arm   |
|           | of SOLVD, only. Additionally, it has a value of 1 when   |
|           | the endpoint EPA is 1, only. Now, EPA=1 when either      |
|           | EPY=1 or EPZ=1, that is, when there is a first instance  |
|           | of new or worsening CHF detected at a hospitalization or |
|           | at a SOLVD follow-up visit. When EPA=1 for Prevention    |
|           | Trial participants, the endpoint EPT has the value of 1  |
|           | if the participant was using digitalis, another          |
|           | inotropic agent, a diuretic, or a vasodilator at         |
|           | baseline ("Y" to items SBF15, SBF16, SBF17Z1, or         |
|           | SBF21Z1, respectively), and has discontinued the use of  |
|           | that medication (not "Y" for items SFE11, SFE12,         |
|           | SFE13Z1, or SFE17Z1, respectively), at some follow-up    |
|           | visit that is before or at most 1 visit after the visit  |
|           | corresponding to the occurrence of the endpoint EPA. The |
|           | endpoint EPT is briefly described as "Development of CHF |
|           | and the need for antifailure therapy" or (per Prevention |
|           | Trial paper) as "Development of CHF and anti-CHF         |
|           | therapy". There are 770 participants who have EPT=1. Use |
|           | the variable EPTTIME, described below, for follow-up     |
|           | time for this event.                                     |
+-----------+----------------------------------------------------------+
| EPTTIME   | Follow-up time in days for endpoint EPT. When EPT=1,     |
|           | EPTTIME is the same as EPATIME. When EPT=0, EPTTIME is   |
|           | the same as FUTIME.                                      |
+-----------+----------------------------------------------------------+
| EPX       | This indicator has the value of 1 when either EPY=1 (see |
|           | below) or EP1=1                                          |
|           |                                                          |
|           | (all-cause mortality -- see earlier), and 0 otherwise.   |
|           | There are 2,302 participants who have EPX=1. Use the     |
|           | variable EPXTIME, described below, for follow-up time    |
|           | for this event.                                          |
+-----------+----------------------------------------------------------+
| EPXTIME   | Follow-up time in days for endpoint EPX. When EPX=1      |
|           | (that is, EPY=1 or EP1=1: CHF hospitalization or         |
|           | all-cause mortality), EPXTIME is the number of days from |
|           | the earlier of the cardiovascular hospitalization date   |
|           | and the date of death, to the date of randomization.     |
|           | When EPX=0, EPXTIME is the same as FUTIME.               |
+-----------+----------------------------------------------------------+
| EPY       | First CHF hospitalization (after randomization) for new  |
|           | or worsening CHF                                         |
|           |                                                          |
|           | (new CHF: SHF7=B; worsening CHF: SHF7=A). There are      |
|           | 1,260 participants who have EPY=1. Use the variable      |
|           | EPYTIME, described below, for follow-up time for this    |
|           | event.                                                   |
+-----------+----------------------------------------------------------+
| EPYTIME   | For EPY=1 (Yes), EPYTIME is the number of days between   |
|           | the first                                                |
|           |                                                          |
|           | hospitalization for condition EPY (obtained from the     |
|           | date SHF4Z1 of that hospitalization) and date of         |
|           | randomization. When EPY=0, EPYTIME is the same as        |
|           | FUTIME.                                                  |
+-----------+----------------------------------------------------------+
| EPZ       | This 0/1 indicator is derived from the SOLVD follow-up   |
|           | form SFE. It designates the first follow-up physician's  |
|           | examination of the participant in which there is         |
|           | evidence that CHF has developed since last follow-up     |
|           | visit (SFE29Z1=Y), or that a previously symptomatic      |
|           | participant's CHF severity has worsened since last       |
|           | follow-up visit (SFE31=W). There are 2,217 participants  |
|           | who have EPZ=1. Use the variable EPZTIME, described      |
|           | below, for follow-up time for this event.                |
+-----------+----------------------------------------------------------+
| EPZTIME   | For EPZ=1 (Yes), EPZTIME is the number of days between   |
|           | the first                                                |
|           |                                                          |
|           | follow-up visit at which the participant is deemed to    |
|           | have the condition EPZ (obtained from the date SFE1 of   |
|           | that follow-up visit) and the date of randomization.     |
|           | When EPZ=0, EPZTIME is the same as FUTIME.               |
+-----------+----------------------------------------------------------+
| FUTIME    | For endpoints EP1-EP18: When the endpoint is 1 (Yes),    |
|           | FUTIME is the number of days between DDATE (date of      |
|           | death) and date of randomization. When the endpoint is 0 |
|           | (No), FUTIME is the number of days between the end of    |
|           | the study and date of randomization. End of study is     |
|           | taken to be January 31, 1991 for the Treatment Trial,    |
|           | and August 31, 1991 for the Prevention Trial.            |
+-----------+----------------------------------------------------------+
| HOSPCODE  | Code for clinic/hospital combination                     |
+-----------+----------------------------------------------------------+
| ID_SOL    | Participant ID for SOLVD LAD data                        |
+-----------+----------------------------------------------------------+
| RDATE     | Date of randomization for each randomized participant.   |
|           | Set to 0 to serve as a reference point for all other     |
|           | dates in the SOLVD LAD data sets.                        |
+-----------+----------------------------------------------------------+
| TRIAL     | Indicator of SOLVD trial to which participant belongs.   |
|           | T=Treatment Trial, P=Prevention Trial.                   |
+-----------+----------------------------------------------------------+
| TRTMENT   | Treatment assignment of each randomized participant.     |
|           | PLAC=Placebo, ENAL=Enalapril.                            |
+-----------+----------------------------------------------------------+

5.  **Data set name: SFD_LAD2**

> **Description: SOLVD Final Designation of Death Form (SFD)**
>
> **Form versions: A, B, C**
>
> **Number of observations: 1599**
>
> **Visit range: 3-20**
>
> **Structure: One observation for each ID_SOL**
>
> **Sort order (unique keys): ID_SOL**

+-----------+-----------------------------+---------------------------+
| #         | # Description               | # Modification/Comment    |
|  Variable |                             |                           |
+-----------+-----------------------------+---------------------------+
| SFD1      | Date form completed         | Standard date             |
|           |                             | transformation            |
+-----------+-----------------------------+---------------------------+
| SFD2      | Date of death               | Standard date             |
|           |                             | transformation            |
+-----------+-----------------------------+---------------------------+
| SFD2AT    | Time of death :             | Version C only            |
|           | Hours/minutes               |                           |
+-----------+-----------------------------+---------------------------+
| SFD2AH    | Time of death : Hours       | Version C only            |
+-----------+-----------------------------+---------------------------+
| SFD2AM    | Time of death : Minutes     | Version C only            |
+-----------+-----------------------------+---------------------------+
| SFD2B     | Time of death : AM/PM       | Version C only            |
+-----------+-----------------------------+---------------------------+
| SFD3Z1    | Participant's last name     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFD3Z2    | Participant's first name    | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFD3Z3    | Participant's middle name   | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFD4Z3    | Condition of death:         | Dropped, count too low    |
|           | Traumatic                   |                           |
+-----------+-----------------------------+---------------------------+
| SFD4Z4    | Condition of death: Suicide | Dropped, count too low    |
+-----------+-----------------------------+---------------------------+
| SFD4Z6    | Condition of death: Within  | Dropped, collapsed into   |
|           | 7 days of cardiac surgery   | SFD4Z6_7 (original count  |
|           |                             | too low)                  |
+-----------+-----------------------------+---------------------------+
| SFD4Z7    | Condition of death: Within  | Dropped, collapsed into   |
|           | 7 days of non-cardiac       | SFD4Z6_7 (original count  |
|           | surgery                     | too low)                  |
+-----------+-----------------------------+---------------------------+
| SFD4Z6_7  | Condition of death: Within  | Y if either SFD4Z6 or     |
|           | 7 days of surgery           | SFD4Z7 is Y, N if both    |
|           |                             | are N                     |
+-----------+-----------------------------+---------------------------+
| SFD6Z1    | Cardiovascular death: Type  | Dropped, collapsed into   |
|           | (Ver A,B)                   | SFD6Z1A                   |
|           |                             |                           |
|           |                             | (original count too low)  |
+-----------+-----------------------------+---------------------------+
| SFD6Z1A   | Cardiovascular death: Type  | Includes non-missing      |
|           | (Ver C)                     | value from SFD6Z1 if      |
|           |                             | original value of SFD6Z1A |
|           |                             | was missing. Values V,O,P |
|           |                             | collapsed into X.         |
+-----------+-----------------------------+---------------------------+
| SFD6Z3A   | Describe "other" most       | Dropped, long text field  |
|           | likely terminal event for   |                           |
|           | cardiac death: Line #1 (Ver |                           |
|           | A,B)                        |                           |
+-----------+-----------------------------+---------------------------+
| SFD6Z3B   | Describe "other" most       | Dropped, long text field  |
|           | likely terminal event for   |                           |
|           | cardiac death: Line #2 (Ver |                           |
|           | A,B)                        |                           |
+-----------+-----------------------------+---------------------------+
| SFD6Z3C   | Describe "other" most       | Dropped, long text field  |
|           | likely terminal event for   |                           |
|           | cardiac death: Line #3 (Ver |                           |
|           | A,B)                        |                           |
+-----------+-----------------------------+---------------------------+
| SFD6Z3D   | Describe "other" most       | Dropped, long text field  |
|           | likely terminal event for   |                           |
|           | cardiac death: Line #4 (Ver |                           |
|           | A,B)                        |                           |
+-----------+-----------------------------+---------------------------+
| SFD6Z3    | Describe "other" most       | Dropped, long text field  |
|           | likely terminal event for   |                           |
|           | cardiac death: Line #1 (Ver |                           |
|           | C)                          |                           |
+-----------+-----------------------------+---------------------------+
| SFD6Z3S   | Describe "other" most       | Dropped, long text field  |
|           | likely terminal event for   |                           |
|           | cardiac death: Line #2 (Ver |                           |
|           | C)                          |                           |
+-----------+-----------------------------+---------------------------+
| SFD6Z3S1  | Describe "other" most       | Dropped, long text field  |
|           | likely terminal event for   |                           |
|           | cardiac death: Line #3 (Ver |                           |
|           | C)                          |                           |
+-----------+-----------------------------+---------------------------+
| SFD6Z3S2  | Describe "other" most       | Dropped, long text field  |
|           | likely terminal event for   |                           |
|           | cardiac death: Line #4 (Ver |                           |
|           | C)                          |                           |
+-----------+-----------------------------+---------------------------+
| SFD7Z3    | Specify primary cancer site | Dropped, long text field  |
+-----------+-----------------------------+---------------------------+
| SFD7Z4    | Specify type of non-cardio  | Dropped, long text field  |
|           | death if neither a primary  |                           |
|           | event nor a secondary       |                           |
|           | complication of heart       |                           |
|           | failure                     |                           |
+-----------+-----------------------------+---------------------------+
| SFD8      | Initials of person          | Dropped, personal         |
|           | completing this form        | information               |
+-----------+-----------------------------+---------------------------+

6.  **Data set name: SFE_LAD2**

> **Description: SOLVD Follow-up Interview/Exam Form (SFE)**
>
> **Form versions: A, B, C**
>
> **Number of observations: 65,158**
>
> **Visit range: 4-20**
>
> **Structure: Multiple observations for each ID_SOL**
>
> **Sort order (unique keys): ID_SOL VISIT**

+-----------+-----------------------------+---------------------------+
| #         | # Description               | # Modification/Comment    |
|  Variable |                             |                           |
+-----------+-----------------------------+---------------------------+
| SFE1      | Date of this interview/exam | Standard date             |
|           |                             | transformation            |
+-----------+-----------------------------+---------------------------+
| SFE2      | Date of last SOLVD          | Standard date             |
|           | interview/exam              | transformation            |
+-----------+-----------------------------+---------------------------+
| SFE3Z1    | Participant's last name     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFE3Z2    | Participant's first name    | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFE3Z3    | Participant's middle name   | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFE4Z1    | Participant's address       | Dropped, personal         |
|           | and/or telephone \# same as | information               |
|           | before?                     |                           |
+-----------+-----------------------------+---------------------------+
| SFE4Z2A   | Street address -- line #1   | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFE4Z2B   | Street address -- line #2   | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFE4Z3    | City                        | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFE4Z4    | State/province              | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFE4Z5    | Country                     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFE4Z6    | Zip code/Canadian or        | Dropped, personal         |
|           | European postal code        | information               |
+-----------+-----------------------------+---------------------------+
| SFE4Z7    | Telephone number (home)     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFE5Z1    | Participant's private       | Dropped, personal         |
|           | physician (name, address,   | information               |
|           | telephone #) same as        |                           |
|           | before?                     |                           |
+-----------+-----------------------------+---------------------------+
| SFE5Z2    | Private physician: Last     | Dropped, personal         |
|           | name                        | information               |
+-----------+-----------------------------+---------------------------+
| SFE5Z3    | Private physician: First    | Dropped, personal         |
|           | name                        | information               |
+-----------+-----------------------------+---------------------------+
| SFE5Z4A   | Private physician: Street   | Dropped, personal         |
|           | address -- line #1          | information               |
+-----------+-----------------------------+---------------------------+
| SFE5Z4B   | Private physician: Street   | Dropped, personal         |
|           | address -- line #2          | information               |
+-----------+-----------------------------+---------------------------+
| SFE5Z5    | Private physician: City     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFE5Z6    | Private physician:          | Dropped, personal         |
|           | State/province              | information               |
+-----------+-----------------------------+---------------------------+
| SFE5Z7    | Private physician: Country  | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFE5Z8    | Private physician: Zip      | Dropped, personal         |
|           | code/Canadian or European   | information               |
|           | postal code                 |                           |
+-----------+-----------------------------+---------------------------+
| SFE5Z9    | Private physician:          | Dropped, personal         |
|           | Telephone number            | information               |
+-----------+-----------------------------+---------------------------+
| SFE6Z1    | Participant's employment    | Dropped, personal         |
|           | (name, title, address,      | information               |
|           | telephone #) same as        |                           |
|           | before?                     |                           |
+-----------+-----------------------------+---------------------------+
| SFE6Z2    | Employer: Name or status    | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFE6Z3    | Participant's job title     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFE6Z4A   | Employer: Street address -- | Dropped, personal         |
|           | line #1                     | information               |
+-----------+-----------------------------+---------------------------+
| SFE6Z4B   | Employer: Street address -- | Dropped, personal         |
|           | line #2                     | information               |
+-----------+-----------------------------+---------------------------+
| SFE6Z5    | Employer: City              | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFE6Z6    | Employer: State/province    | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFE6Z7    | Employer: Country           | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFE6Z8    | Employer: Zip code/Canadian | Dropped, personal         |
|           | or European postal code     | information               |
+-----------+-----------------------------+---------------------------+
| SFE6Z9    | Employer: Telephone number  | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFE6Z10   | Participant's nearest       | Dropped, personal         |
|           | relative or friend's        | information               |
|           | address and phone \# same   |                           |
|           | as before? (Ver C)          |                           |
+-----------+-----------------------------+---------------------------+
| SFE7Z2    | Average \# of angina        | Top/bottom coding:        |
|           | attacks per week            |                           |
|           |                             | Values above 35 recoded   |
|           |                             | to 35.                    |
+-----------+-----------------------------+---------------------------+
| SFE17Z2   | Currently on long-acting    | Versions A only           |
|           | nitrate                     |                           |
+-----------+-----------------------------+---------------------------+
| SFE17Z2A  | Currently on oral nitrate   | Renamed to SFE17Z2        |
|           | (Ver B), on long-acting     |                           |
|           | nitrate (Ver C)             |                           |
+-----------+-----------------------------+---------------------------+
| SFE18Z1   | Currently on other          | Version C only            |
|           | vasodilator                 |                           |
+-----------+-----------------------------+---------------------------+
| SFE23Z3   | Taste disturbance (Ver A,B) | Version-specific          |
|           | -- Altered taste (Ver C)    |                           |
|           | since last visit            |                           |
+-----------+-----------------------------+---------------------------+
| SFE23Z6A  | Angioneurotic edema since   | Version C only            |
|           | last visit                  |                           |
+-----------+-----------------------------+---------------------------+
| SFE23Z6B  | Cough since last visit      | Version C only            |
+-----------+-----------------------------+---------------------------+
| SFE23Z8S  | Specify other symptoms      | Recoded into symptom      |
|           | since last visit            | categories. See note      |
|           |                             | below this table.         |
+-----------+-----------------------------+---------------------------+
| SFE24Z1   | Weight (to nearest lb)      | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 100 recoded  |
|           |                             | to 100.                   |
|           |                             |                           |
|           |                             | Values above 300 recoded  |
|           |                             | to 300.                   |
+-----------+-----------------------------+---------------------------+
| SFE24Z2   | Weight (to nearest kg)      | Top/bottom coding:        |
|           |                             |                           |
|           | Note: When weight is        | Values below 45 recoded   |
|           | available in both lb and    | to 45.                    |
|           | kg, the value is lb is      |                           |
|           | generally more trustworthy  | Values above 136 recoded  |
|           |                             | to 136.                   |
+-----------+-----------------------------+---------------------------+
| SFE25     | Heart rate (sitting) (beats | Top/bottom coding:        |
|           | per minute)                 |                           |
|           |                             | Values below 40 recoded   |
|           |                             | to 40.                    |
|           |                             |                           |
|           |                             | Values above 130 recoded  |
|           |                             | to 130.                   |
+-----------+-----------------------------+---------------------------+
| SFE26Z1   | Systolic BP (sitting) (mm   | Top/bottom coding:        |
|           | Hg)                         |                           |
|           |                             | Values below 70 recoded   |
|           |                             | to 70.                    |
|           |                             |                           |
|           |                             | Values above 200 recoded  |
|           |                             | to 200.                   |
+-----------+-----------------------------+---------------------------+
| SFE26Z2   | Diastolic BP (sitting) (mm  | Top/bottom coding:        |
|           | Hg)                         |                           |
|           |                             | Values below 40 recoded   |
|           |                             | to 40.                    |
|           |                             |                           |
|           |                             | Values above 120 recoded  |
|           |                             | to 120.                   |
+-----------+-----------------------------+---------------------------+
| SFE30Z4   | Sign of CHF: S3 gallop (Ver | Version-specific          |
|           | A,B) -- S3 (Ver C)          |                           |
+-----------+-----------------------------+---------------------------+
| SFE32     | Hematocrit (HCT) (%)        | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 15 recoded   |
|           |                             | to 15.                    |
|           |                             |                           |
|           |                             | Values above 55 recoded   |
|           |                             | to 55.                    |
+-----------+-----------------------------+---------------------------+
| SFE33Z1   | Total white blood count     | Top/bottom coding:        |
|           | (WBC x 1000)                |                           |
|           |                             | Values below 3 recoded to |
|           |                             | 3.                        |
|           |                             |                           |
|           |                             | Values above 20 recoded   |
|           |                             | to 20.                    |
+-----------+-----------------------------+---------------------------+
| SFE33Z2   | Percent neutrophils         | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 20 recoded   |
|           |                             | to 20.                    |
|           |                             |                           |
|           |                             | Values above 90 recoded   |
|           |                             | to 90.                    |
+-----------+-----------------------------+---------------------------+
| SFE33Z3   | Percent lymphocytes         | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 3 recoded to |
|           |                             | 3.                        |
|           |                             |                           |
|           |                             | Values above 65 recoded   |
|           |                             | to 65.                    |
+-----------+-----------------------------+---------------------------+
| SFE34     | Sodium (Na) (meq/l)         | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 125 recoded  |
|           |                             | to 125.                   |
|           |                             |                           |
|           |                             | Values above 150 recoded  |
|           |                             | to 150.                   |
+-----------+-----------------------------+---------------------------+
| SFE35     | Potassium (K) (meq/l)       | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 2.7 recoded  |
|           |                             | to 2.7.                   |
|           |                             |                           |
|           |                             | Values above 6.5 recoded  |
|           |                             | to 6.5.                   |
+-----------+-----------------------------+---------------------------+
| SFE36     | Blood urea nitrogen (BUN)   | Top/bottom coding:        |
|           | (mg/dl)                     |                           |
|           |                             | Values below 5 recoded to |
|           |                             | 5.                        |
|           |                             |                           |
|           |                             | Values above 61 recoded   |
|           |                             | to 61.                    |
+-----------+-----------------------------+---------------------------+
| SFE37     | Creatinine (mg/dl)          | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 0.4 recoded  |
|           |                             | to 0.4.                   |
|           |                             |                           |
|           |                             | Values above 3.5 recoded  |
|           |                             | to 3.5.                   |
+-----------+-----------------------------+---------------------------+
| SFE38     | Proteinurea (0-4) (1="+")   | Collapsed into C0 (0), C1 |
|           | (Ver A)                     | (1), C2 (2), C3_4 (3, 4). |
+-----------+-----------------------------+---------------------------+
| SFE38A    | Proteinurea (0-4) (1="trace | Collapsed into C0 (0), C1 |
|           | or +") (Ver B,C)            | (1), C2 (2), C3_4 (3, 4). |
+-----------+-----------------------------+---------------------------+
| SFE41     | Type of change in dosage:   | Versions A, B only        |
|           | Increase/decrease           |                           |
+-----------+-----------------------------+---------------------------+
| SFE42Z1   | Increase toward prescribed  | Versions A, B only        |
|           | maintenance dose following  |                           |
|           | dose reduction              |                           |
+-----------+-----------------------------+---------------------------+
| SFE42Z2   | Increase toward prescribed  | Versions A, B only        |
|           | maintenance dose by         |                           |
|           | protocol                    |                           |
+-----------+-----------------------------+---------------------------+
| SFE42Z3   | Other reason for increasing | Dropped, count too low    |
|           | dose (Ver A,B)              |                           |
+-----------+-----------------------------+---------------------------+
| SFE42Z3S  | Describe other reason for   | Dropped, count too low    |
|           | increasing dose (Ver A,B)   |                           |
+-----------+-----------------------------+---------------------------+
| SFE43Z1   | Decreasing dose, due to     | Low count: 341 responses  |
|           | side effects (Ver A,B)      | of Yes, only. So, all     |
|           |                             | variables from SFE43Z2 to |
|           |                             | SFE51S are dropped        |
+-----------+-----------------------------+---------------------------+
| SFE43Z2   | Decreasing dose, due to     | Dropped, count too low    |
|           | symptomatic hypotension     |                           |
|           | (Ver A,B)                   |                           |
+-----------+-----------------------------+---------------------------+
| SFE43Z3   | Decreasing dose, due to     | Dropped, count too low    |
|           | taste abnormalities (Ver    |                           |
|           | A,B)                        |                           |
+-----------+-----------------------------+---------------------------+
| SFE43Z4   | Decreasing dose, due to     | Dropped, count too low    |
|           | skin rash (Ver A,B)         |                           |
+-----------+-----------------------------+---------------------------+
| SFE43Z5   | Decreasing dose, due to     | Dropped, count too low    |
|           | azotemia (Ver A,B)          |                           |
+-----------+-----------------------------+---------------------------+
| SFE43Z6   | Decreasing dose, due to     | Dropped, count too low    |
|           | Other Reason (Ver A,B)      |                           |
+-----------+-----------------------------+---------------------------+
| SFE43Z6S  | Decreasing dose: Specify    | Dropped, long text field  |
|           | other reason (Ver A,B)      |                           |
+-----------+-----------------------------+---------------------------+
| SFE44     | Myocardial infarction (Ver  | Dropped, count too low    |
|           | A,B)                        |                           |
+-----------+-----------------------------+---------------------------+
| SFE45Z1   | Cardiac surgery other than  | Dropped, count too low    |
|           | transplant (Ver A,B)        |                           |
+-----------+-----------------------------+---------------------------+
| SFE45Z2   | Specify cardiac surgery     | Dropped, long text field  |
|           | other than transplant (Ver  |                           |
|           | A,B)                        |                           |
+-----------+-----------------------------+---------------------------+
| SFE46     | Cardiac transplant (Ver     | Dropped, count too low    |
|           | A,B)                        |                           |
+-----------+-----------------------------+---------------------------+
| SFE47     | Noncardiac surgery (Ver     | Dropped, count too low    |
|           | A,B)                        |                           |
+-----------+-----------------------------+---------------------------+
| SFE48     | Worsening CHF: needs study  | Dropped, count too low    |
|           | drug or similar medication  |                           |
|           | (Ver A,B)                   |                           |
+-----------+-----------------------------+---------------------------+
| SFE49     | Requested by referring      | Dropped, count too low    |
|           | physician (Ver A,B)         |                           |
+-----------+-----------------------------+---------------------------+
| SFE50     | Requested by participant    | Dropped, count too low    |
|           | (Ver A,B)                   |                           |
+-----------+-----------------------------+---------------------------+
| SFE51     | "Other" (Ver A,B)           | Dropped, count too low    |
+-----------+-----------------------------+---------------------------+
| SFE51S    | Specify "other" (Ver A,B)   | Dropped, long text field  |
+-----------+-----------------------------+---------------------------+
| SFE52     | Date of next visit          | Dropped, no longer        |
|           |                             | relevant                  |
+-----------+-----------------------------+---------------------------+
| SFE53     | Form completed at clinic or | Version-specific          |
|           | by telephone (Ver A,B) - at |                           |
|           | clinic or by telephone or   |                           |
|           | at hospital (Ver C)         |                           |
+-----------+-----------------------------+---------------------------+
| SFE54     | Initials of person          | Dropped, personal         |
|           | completing this form        | information               |
+-----------+-----------------------------+---------------------------+

> **Symptom categories used for variable SFE23Z8S**:
>
> 1 = Dizziness/Fainting (Light Headed, near syncope)/orthostatic
> symptoms, Syncope,
>
> Ataxia, vertigo, Hypotension
>
> 2 = Skin Rash/pruritis, Itching/urticaria/hives/gingivitis/dry
> skin/nail changes
>
> 3 = Taste/smell disturbance
>
> 4 = Blurred vision, Vision problem/eye aches/ eye floater/ watery
> eyes/ conjunctivitis
>
> 5 = Fatigue, drowsiness, lethargy, malaise, weakness, heat intolerance
>
> 6 = Nausea/indigestion/epigastric pain/bloating
>
> 7 = Forgetfulness, confusion, slow thought
>
> 8 = Headache
>
> 9 = Cough
>
> 10 = Chest pain/angina, worsening or unstable angina
>
> 11 = GI symptoms: Diarrhea, Constipation, Stomach pain/abdominal pain,
> Loss of

appetite/weight loss

> 12 = Heart irregularity-arrhythmia, palpitations
>
> 13 = Azotemia (incr. creatinine or BUN), renal failure, Hyperkalemia,
> Proteinuria
>
> 14 = Urinary problem, Nocturia, urinary freq.
>
> 15 = CNS symptoms: Sleep disturbance, Numbness/tingling/parasthesia,
> Ear
>
> problem /tinitus/hearing loss,
> Irritable/nervous/anxiety/tension/personality

change/dementia, Backache, Depression, Tremor

> 16 = Leg pain/weakness/claudication/PVD, cold feet, Raynaud\'s
>
> 17 = Sweating/diaphoresis
>
> 18 = Dryness in mouth/thirst
>
> 19 = Arthritis, carpal tunnel, gout, joint pain
>
> 20 = Possible angioedema
>
> 21 = Stroke/TIA, subdural hematoma
>
> 22 = Hyponatremia
>
> 23 =Easy bruising, decreased platelets, ecchymosis, decreased
> Hematocrit
>
> 24 = Other symptoms: Impotence, sexual dysfunction, decreased libido,
> Leukocytosis,
>
> Chills/cold, flu, fever/nasal discharge/throat
> irritation/bronchitis/dry mouth,
>
> Leukopenia, Nose bleed, epistaxsis, Hemoptysis, Hyperglycemia (incr.
> glucose),
>
> hair loss, alopecia, Cancer, Miscellaneous GI symptoms/ gastritis/
> difficulty
>
> swallowing, Musculoskeletal problems, Menopausal symptoms, vaginal
> bleeding,
>
> Hypertension, Hypothyroidism, Seizures, Gynecomastia, tender breasts,
> Pleuritic
>
> pain, wheezing, Hypokalemia, Hair on abdomen, Hiccoughs, Other
>
> miscellaneous
>
> 25 = Not given -- set to missing
>
> 26 = CHF Symptoms, include: Pedal Edema, orthopnea/lung congestion;
> SOB, Weight

gain, Acute dyspnea

> Note: categories 13 (Azotemia, etc.) and 23 (Easy bruising, etc.) were
> collapsed into category

24=Other symptoms, due to sparseness of counts.

7.  **Data set name: SFN_LAD2**

> **Description: SOLVD First Notification of Death Form (SFN)**
>
> **Form versions: A**
>
> **Number of observations: 1591**
>
> **Visit range: 3-20**
>
> **Structure: One observation for each ID_SOL**
>
> **Sort order (unique keys): ID_SOL**

+-----------+-----------------------------+---------------------------+
| #         | # Description               | # Modification/Comment    |
|  Variable |                             |                           |
+-----------+-----------------------------+---------------------------+
| SFN1      | Date form completed         | Standard date             |
|           |                             | transformation            |
+-----------+-----------------------------+---------------------------+
| SFN2Z1    | Participant's last name     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFN2Z2    | Participant's first name    | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFN2Z3    | Participant's middle name   | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SFN3      | Date of death (to the best  | Standard date             |
|           | of informant's knowledge)   | transformation            |
+-----------+-----------------------------+---------------------------+
| SFN4      | Initials of person          | Dropped, personal         |
|           | completing this form        | information               |
+-----------+-----------------------------+---------------------------+

8.  **Data set name: SHF_LAD2**

> **Description: SOLVD Hospitalization Form (SHF)**
>
> **Form versions: A, B**
>
> **Number of observations: 10,773**
>
> **Visit range: 2-19**
>
> **Structure: Multiple observations for each ID_SOL and possibly for
> each ID_SOL and VISIT**
>
> **Sort order (unique keys): ID_SOL VISIT VISSEQ**

+-----------+-----------------------------+---------------------------+
| #         | # Description               | # Modification/Comment    |
|  Variable |                             |                           |
+-----------+-----------------------------+---------------------------+
| SHF1      | Date form completed         | Standard date             |
|           |                             | transformation            |
+-----------+-----------------------------+---------------------------+
| SHF2Z1    | Participant's last name     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SHF2Z2    | Participant's first name    | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SHF2Z3    | Participant's middle name   | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SHF3      | Hospital name               | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SHF4Z1    | Date of admission           | Standard date             |
|           |                             | transformation            |
+-----------+-----------------------------+---------------------------+
| SHF4Z2    | Date of discharge           | Standard date             |
|           |                             | transformation            |
+-----------+-----------------------------+---------------------------+
| SHF6A     | Primary reason for hosp is  | Text in variables SHF6A   |
|           | non-CV: Specify: Line #1    | and SHF6B was used for    |
|           |                             | developing a single ICD9  |
|           |                             | code according to         |
|           |                             | standard 3-digit ICD9     |
|           |                             | categories as summarized  |
|           |                             | below this table          |
+-----------+-----------------------------+---------------------------+
| SHF6B     | Primary reason for hosp is  | (See variable SHF6A).     |
|           | non-CV: Specify: Line #2    | Dropped (long text        |
|           |                             | field), after developing  |
|           |                             | ICD9 code                 |
+-----------+-----------------------------+---------------------------+
| SHF7      | Primary reason for hosp is  | Sparse levels K, L, M, N, |
|           | CV: Code for primary reason | O collapsed into level X  |
+-----------+-----------------------------+---------------------------+
| SHF7A     | Primary reason for hosp is  | Standard date             |
|           | MI: Date of MI (Ver B)      | transformation            |
+-----------+-----------------------------+---------------------------+
| SHF7B     | Primary reason for hosp is  | Version B only            |
|           | MI: Time of MI              |                           |
+-----------+-----------------------------+---------------------------+
| SHF7BH    | Primary reason for hosp is  | Version B only            |
|           | MI: Time of MI: Hour        |                           |
+-----------+-----------------------------+---------------------------+
| SHF7BM    | Primary reason for hosp is  | Version B only            |
|           | MI: Time of MI: Minute      |                           |
+-----------+-----------------------------+---------------------------+
| SHF7C     | Primary reason for hosp is  | Version B only            |
|           | MI: Time of MI: AM/PM       |                           |
+-----------+-----------------------------+---------------------------+
| SHF9Z1    | Primary reason for hosp is  | Sparse levels B, T, V, O  |
|           | cardiac surgery: Type of    | collapsed into level X    |
|           | cardiac surgery             |                           |
+-----------+-----------------------------+---------------------------+
| SHF9Z2    | Primary reason for hosp is  | Dropped, long text field  |
|           | cardiac surgery: Specify    |                           |
|           | other cardiac surgery       |                           |
+-----------+-----------------------------+---------------------------+
| SHF10     | Primary reason for hosp is  | Codes 1-40 were developed |
|           | any other major event:      | from text. and are        |
|           | Specify                     | explained below this      |
|           |                             | table.                    |
+-----------+-----------------------------+---------------------------+
| SHF12A    | Secondary reason for hosp   | Dropped, long text field  |
|           | is non-CV: Specify: Line #1 |                           |
+-----------+-----------------------------+---------------------------+
| SHF12B    | Secondary reason for hosp   | Dropped, long text field  |
|           | is non-CV: Specify: Line #2 |                           |
+-----------+-----------------------------+---------------------------+
| SHF16Z1A  | Secondary reason for hosp   | Standard date             |
|           | is MI: Date of MI (Ver B)   | transformation            |
+-----------+-----------------------------+---------------------------+
| SHF16Z1B  | Secondary reason for hosp   | Version B only            |
|           | is MI: Time of MI           |                           |
+-----------+-----------------------------+---------------------------+
| SHF16BH   | Secondary reason for hosp   | Version B only            |
|           | is MI: Time of MI: Hour     |                           |
+-----------+-----------------------------+---------------------------+
| SHF16BM   | Secondary reason for hosp   | Version B only            |
|           | is MI: Time of MI: Minute   |                           |
+-----------+-----------------------------+---------------------------+
| SHF16Z1C  | Secondary reason for hosp   | Version B only            |
|           | is MI: Time of MI: AM/PM    |                           |
+-----------+-----------------------------+---------------------------+
| SHF22Z2   | Secondary reason for hosp   | Sparse levels B, T, V, O  |
|           | is cardiac surgery: Type of | collapsed into level X    |
|           | cardiac surgery             |                           |
+-----------+-----------------------------+---------------------------+
| SHF22Z3   | Secondary reason for hosp   | Dropped, long text field  |
|           | is cardiac surgery: Specify |                           |
|           | other cardiac surgery       |                           |
+-----------+-----------------------------+---------------------------+
| SHF23     | Secondary reason for hosp   | Collapsed into SHF27Z1X   |
|           | is pulmonary embolism       | and then dropped          |
+-----------+-----------------------------+---------------------------+
| SHF24     | Secondary reason for hosp   | Collapsed into SHF27Z1X   |
|           | is peripheral embolism      | and then dropped          |
+-----------+-----------------------------+---------------------------+
| SHF25     | Secondary reason for hosp   | Collapsed into SHF27Z1X   |
|           | is hypotension              | and then dropped          |
+-----------+-----------------------------+---------------------------+
| SHF26     | Secondary reason for hosp   | Collapsed into SHF27Z1X   |
|           | is azotemia                 | and then dropped          |
+-----------+-----------------------------+---------------------------+
| SHF27Z1   | Secondary reason for hosp   | Collapsed into SHF27Z1X   |
|           | is any other major event    | and then dropped          |
+-----------+-----------------------------+---------------------------+
| SHF27Z1X  | Secondary reason for hosp   | Recoded to include        |
|           | is SHF23-26 or SHF27Z1      | information from SHF23,   |
|           |                             | SHF24, SHF25, SHF26, and  |
|           |                             | SHF27Z1                   |
+-----------+-----------------------------+---------------------------+
| SHF27Z2   | Secondary reason for hosp   | Dropped, long text field  |
|           | is any other major event:   |                           |
|           | Specify                     |                           |
+-----------+-----------------------------+---------------------------+
| SHF28     | Initials of person          | Dropped, personal         |
|           | completing this form        | information               |
+-----------+-----------------------------+---------------------------+

**ICD9 categories for variable SHF6a**:

> . = Blank
>
> 1 = Infectious and Parasitic Diseases (001-139)
>
> 2 = Neoplasms (140-239)
>
> 3 = Endocrine, Nutritional, and Metabolic Diseases and Immunity
> Disorders (240-279)
>
> 4 = Diseases of the Blood and Blood-Forming Organs (280-289)
>
> 5 = Mental Disorders (290-319)
>
> 6 = Diseases of the Nervous System and Sense Organs (320-389)
>
> 7 = Diseases of the Circulatory System (390-459)
>
> 8 = Diseases of the Respiratory System (460-519)
>
> 9 = Diseases of the Digestive System (520-579)
>
> 10 = Diseases of the Genitourinary System (580-629)
>
> 11 = Complications of Pregnancy, Childbirth, and the Puerperium
> (630-676)
>
> 12 = Diseases of the Skin and Subcutaneous Tissue (680-709)
>
> 13 = Diseases of the Musculoskeletal System and Connective Tissue
> (710-739)
>
> 14 = Congenital Anomalies (740-759)
>
> 15 = Certain Conditions Originating in the Perinatal Period (760-779)
>
> 16 = Symptoms, Signs, and Ill-Defined Conditions (780-799)
>
> 17 = Injury and Poisoning (800-999)
>
> 18 = External Causes of Injury and Poisoning (E800 - E999)
>
> 19 = Supplementary Codes (V01 - V82)
>
> 20 = Other ICD9 Code
>
> Note: categories 7 (Diseases of the Circulatory System) and 14
> (Congenital Anomalies) were
>
> recoded into category 20 (Other ICD9 codes), due to sparseness of
> counts. Sparse counts were expected for category 7, as variables
> SHF6A-B are text descriptions of non-cardiovascular hospitalizations.

**Categories for variable SHF10**:

> 1 = Worsening or new CHF, Pulmonary Edema
>
> 2 = Worsening or new angina/ASHD/SOB
>
> 3 = Myocardial infarction
>
> 4 = Cardiac arrest
>
> 5 = Supraventricular tachycardia
>
> 6 = Uncertain tachycardia
>
> 7 = Other arrhythmias + (Bradycardia, Atrial node dysfunction)
>
> 8 = Stroke
>
> 9 = Cardiac surgery
>
> 10 = Cardiac surgery - graft
>
> 11 = Cardiac surgery - valve
>
> 12 = Cardiac surgery - transplantation
>
> 13 = Cardiac surgery - graft and valve
>
> 14 = Cardiac surgery - other
>
> (Other cardiac surgery includes pacemaker replacement & adjustment and
> AV node
>
> ablation, AICD placement-revision, Cardiac Aneurysm (pseudo or real),
>
> Sympathomectomy)
>
> 15 = Pulmonary embolism/Infarction
>
> 16 = Peripheral embolism
>
> 17 = Hypotension
>
> 18 = Azotemia/Renal Failure/Uremia
>
> 19 = Syncope, dizziness / Vertigo/ Fainting/ Near Syncope
>
> 20 = TIA
>
> 21 = Cardiac/Coronary angiography/ rt or lf cather.
>
> 22 = Chest pain R/O MI, evaluation /Substudy Control
>
> 23 = Transplant evaluation
>
> 24 = Peripheral vasc. eval/surgery, BKA, ASHD, Carotid Arterial
> Stenosis, PVD,
>
> Angiogram, AAA / Peripheral vascular PTCA
>
> 25 = Pericarditis/pleuritis/SBE / Pleural Effusion / Post thoracotomy
> Syndrome
>
> 26 = Electrophysiologic testing/ Holter monitoring (EP Studies)
>
> 27 = Thrombophlebitis / DVT
>
> 28 = Coronary angioplasty, PTCA
>
> 29 = Atrial fibrillation/ flutter
>
> 30 = Hypokalemia/dehydration, Electrolyte imbalance
>
> 31 = Hypertension/ ASHD, HTN
>
> 32 = Hyperkalemia
>
> 33 = Digoxin toxicity
>
> 34 = CV medication adjustment
>
> 35 = Ruptured aneurysm
>
> 36 = Venous insufficiency / Bilateral leg swelling
>
> 37 = Subdurnal Hemorrhage
>
> 38 = TP Rejection
>
> 39 = Valvular Heart Disease
>
> 40 = Other cardiovascular reason

Note: categories 1-14 are redundant with levels A-J of variable SHF7 and
with the levels of

> variable SHF9Z1, and so they contained sparse counts. Therefore, they
> were blanked out. Categories 29-39 also contained small counts, and
> were collapsed into category 40 (Other cardiovascular reason).

9.  **Data set name: SMT_LAD2**

> **Description: SOLVD Medication Tolerance Visit Form (SMT)**
>
> **Form versions: A, B, C**
>
> **Number of observations: 6796**
>
> **Visit range: 2**
>
> **Structure: One observation for each ID_SOL**
>
> **Sort order (unique keys): ID_SOL**

+-----------+-----------------------------+---------------------------+
| #         | # Description               | # Modification/Comment    |
|  Variable |                             |                           |
+-----------+-----------------------------+---------------------------+
| SMT1      | Date form completed         | Standard date             |
|           |                             | transformation            |
+-----------+-----------------------------+---------------------------+
| SMT2Z1    | Participant's last name     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SMT2Z2    | Participant's first name    | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SMT2Z3    | Participant's middle name   | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SMT3Z1    | Systolic blood pressure --  | Top/bottom coding:        |
|           | sitting (mm Hg)             |                           |
|           |                             | Values below 80 recoded   |
|           |                             | to 80.                    |
|           |                             |                           |
|           |                             | Values above 180 recoded  |
|           |                             | to 180.                   |
+-----------+-----------------------------+---------------------------+
| SMT3Z2    | Diastolic blood pressure -- | Top/bottom coding:        |
|           | sitting (mm Hg)             |                           |
|           |                             | Values below 50 recoded   |
|           |                             | to 50.                    |
|           |                             |                           |
|           |                             | Values above 110 recoded  |
|           |                             | to 110.                   |
+-----------+-----------------------------+---------------------------+
| SMT4      | Heart rate -- sitting       | Top/bottom coding:        |
|           | (beats per minute)          |                           |
|           |                             | Values below 46 recoded   |
|           |                             | to 46.                    |
|           |                             |                           |
|           |                             | Values above 112 recoded  |
|           |                             | to 112.                   |
+-----------+-----------------------------+---------------------------+
| SMT5A     | Participant given 2^nd^     | Versions B, C only        |
|           | chance for med tolerance?   |                           |
+-----------+-----------------------------+---------------------------+
| SMT5B     | Participant using non-ACE   | Version C only            |
|           | vasodilators?               |                           |
+-----------+-----------------------------+---------------------------+
| SMT6Z2    | Indication for continuing   | Dropped, long text field  |
|           | use of all non-ACE          |                           |
|           | vasodilators                |                           |
+-----------+-----------------------------+---------------------------+
| SMT7Z4    | Not tolerated med -- skin   | Collapsed into variable   |
|           | rash                        | SMT7Z6X and then dropped  |
+-----------+-----------------------------+---------------------------+
| SMT7Z4A   | Not tolerated med --        | Version C only            |
|           | dizziness/fainting          |                           |
+-----------+-----------------------------+---------------------------+
| SMT7Z4B   | Not tolerated med --        | Version C only            |
|           | fatigue                     |                           |
+-----------+-----------------------------+---------------------------+
| SMT7Z4C   | Not tolerated med -- nausea | Collapsed into variable   |
|           | (Ver C)                     | SMT7Z6X and then dropped  |
+-----------+-----------------------------+---------------------------+
| SMT7Z4D   | Not tolerated med --        | Collapsed into variable   |
|           | angioneurotic edema (Ver C) | SMT7Z6X and then dropped  |
+-----------+-----------------------------+---------------------------+
| SMT7Z4E   | Not tolerated med -- cough  | Collapsed into variable   |
|           | (Ver C)                     | SMT7Z6X and then dropped  |
+-----------+-----------------------------+---------------------------+
| SMT7Z5    | Not tolerated med -- did    | Collapsed into variable   |
|           | not take med                | SMT7Z6X and then dropped  |
+-----------+-----------------------------+---------------------------+
| SMT7Z6    | Not tolerated med -- other  | Collapsed into variable   |
|           | reason                      | SMT7Z6X and then dropped  |
+-----------+-----------------------------+---------------------------+
| SMT7Z6X   | Not tolerated med -- reason | Includes information from |
|           | from SMT7Z4, SMT7Z4C,       | SMT7Z4, SMT7Z4C, SMT7Z4D, |
|           | SMT7Z4D, SMT7Z4E, SMT7Z5,   | SMT7Z4E, SMT7Z5, and      |
|           | and SMT7Z6                  | SMT7Z6                    |
+-----------+-----------------------------+---------------------------+
| SMT7Z6S   | Not tolerated med --        | Dropped, long text field, |
|           | specify other reason        | counts too low in         |
|           |                             | categories and overall    |
+-----------+-----------------------------+---------------------------+
| SMT7Z7    | Participant willing to      | Dropped, not relevant for |
|           | continue on med despite     | randomized participants   |
|           | side effects?               |                           |
+-----------+-----------------------------+---------------------------+
| SMT7Z7A   | Does participant still meet | Dropped, not relevant for |
|           | inclusion criteria? (Ver    | randomized participants   |
|           | B,C)                        |                           |
+-----------+-----------------------------+---------------------------+
| SMT7Z7B   | \# of most important        | Dropped, not relevant for |
|           | inclusion criteria not met  | randomized participants   |
|           | (Ver B,C)                   |                           |
+-----------+-----------------------------+---------------------------+
| SMT8      | Initials of person          | Dropped, personal         |
|           | completing this form        | information               |
+-----------+-----------------------------+---------------------------+
| SMT9      | Participant still eligible  | Dropped, not relevant for |
|           | to continue in SOLVD?       | randomized participants   |
+-----------+-----------------------------+---------------------------+
| SMT10     | Hematocrit (HCT) (%)        | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 29 recoded   |
|           |                             | to 29.                    |
|           |                             |                           |
|           |                             | Values above 54 recoded   |
|           |                             | to 54.                    |
+-----------+-----------------------------+---------------------------+
| SMT11Z1   | Total white blood count     | Top/bottom coding:        |
|           | (WBC x 1000)                |                           |
|           |                             | Values below 3 recoded to |
|           |                             | 3.                        |
|           |                             |                           |
|           |                             | Values above 15 recoded   |
|           |                             | to 15.                    |
+-----------+-----------------------------+---------------------------+
| SMT11Z2   | Percent neutrophils         | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 29 recoded   |
|           |                             | to 29.                    |
|           |                             |                           |
|           |                             | Values above 86 recoded   |
|           |                             | to 86.                    |
+-----------+-----------------------------+---------------------------+
| SMT11Z3   | Percent lymphocytes         | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 6 recoded to |
|           |                             | 6.                        |
|           |                             |                           |
|           |                             | Values above 60 recoded   |
|           |                             | to 60.                    |
+-----------+-----------------------------+---------------------------+
| SMT12     | Sodium (Na) (meq/l)         | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 129 recoded  |
|           |                             | to 129.                   |
|           |                             |                           |
|           |                             | Values above 148 recoded  |
|           |                             | to 148.                   |
+-----------+-----------------------------+---------------------------+
| SMT13     | Potassium (K) (meq/l)       | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 3.2 recoded  |
|           |                             | to 3.2.                   |
|           |                             |                           |
|           |                             | Values above 5.9 recoded  |
|           |                             | to 5.9.                   |
+-----------+-----------------------------+---------------------------+
| SMT14     | Blood urea nitrogen (BUN)   | Top/bottom coding:        |
|           | (mg/dl)                     |                           |
|           |                             | Values below 6 recoded to |
|           |                             | 6.                        |
|           |                             |                           |
|           |                             | Values above 50 recoded   |
|           |                             | to 50.                    |
+-----------+-----------------------------+---------------------------+
| SMT15     | Creatinine (mg/dl)          | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 0.5 recoded  |
|           |                             | to 0.5.                   |
|           |                             |                           |
|           |                             | Values above 2.5 recoded  |
|           |                             | to 2.5.                   |
+-----------+-----------------------------+---------------------------+
| SMT16     | Proteinurea (0-4) (1="+")   | Collapsed into C0 (0), C1 |
|           | (Ver A)                     | (1), C2 (2), C3_4 (3, 4). |
+-----------+-----------------------------+---------------------------+
| SMT16A    | Proteinurea (0-4) (1="trace | Collapsed into C0 (0), C1 |
|           | or +") (Ver B,C)            | (1), C2 (2), C3_4 (3, 4). |
+-----------+-----------------------------+---------------------------+
| SMT17Z1   | Participant still suitable  | Dropped, not relevant for |
|           | to continue?                | randomized participants   |
+-----------+-----------------------------+---------------------------+
| SMT17Z2   | Specify reason(s) for       | Dropped, not relevant for |
|           | participant not suitable to | randomized participants   |
|           | continue                    |                           |
+-----------+-----------------------------+---------------------------+
| SMT17Z3   | Scheduled date of baseline  | Standard date             |
|           | visit 3 (randomization)     | transformation            |
+-----------+-----------------------------+---------------------------+

10. **Data set name: SQL_LAD2**

> **Description: SOLVD Quality of Life Form (SQL)**
>
> **Form versions: A, B**
>
> **Number of observations: 17,522**
>
> **Visit range: 3-20**
>
> **Structure: Multiple observations for each ID_SOL**
>
> **Sort order (unique keys): ID_SOL VISIT**

+-----------+-----------------------------+---------------------------+
| #         | # Description               | # Modification/Comment    |
|  Variable |                             |                           |
+-----------+-----------------------------+---------------------------+
| SQLA      | Date form completed         | Standard date             |
|           |                             | transformation            |
+-----------+-----------------------------+---------------------------+
| SQLB      | Participant's last name     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SQLC      | Participant's first name    | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SQLD      | Participant's middle name   | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SQLE      | Initials of person          | Dropped, personal         |
|           | completing this form        | information               |
+-----------+-----------------------------+---------------------------+
| SQL22CA   | During last month, how      | Version B only            |
|           | difficult was it for        |                           |
|           | participant to walk 1 block |                           |
|           | or climb 1 flight of        |                           |
|           | stairs?                     |                           |
+-----------+-----------------------------+---------------------------+
| SQL23A    | Describe current work (or   | Dropped, long text field  |
|           | last job) of participant,   |                           |
|           | if 'other'                  |                           |
+-----------+-----------------------------+---------------------------+
| SQL30S    | Describe reason for         | Dropped, long text field  |
|           | participant being forced to |                           |
|           | retire, when it is 'other'  |                           |
+-----------+-----------------------------+---------------------------+
| SQL32     | Participant is retired:     | Top/bottom coding:        |
|           | Participant's age at        |                           |
|           | retirement                  | Values below 40 recoded   |
|           |                             | to 40.                    |
|           |                             |                           |
|           |                             | Values above 75 recoded   |
|           |                             | to 75.                    |
+-----------+-----------------------------+---------------------------+
| SQL36     | Participant's gender        | Dropped, use SEF9         |
+-----------+-----------------------------+---------------------------+
| SQL37     | Participant's age           | Dropped, use SEF_AGE      |
+-----------+-----------------------------+---------------------------+
| SQL38     | Highest grade participant   | Top/bottom coding:        |
|           | completed in school         |                           |
|           |                             | Values below 2 recoded to |
|           |                             | 2.                        |
|           |                             |                           |
|           |                             | Values above 22 recoded   |
|           |                             | to 22.                    |
+-----------+-----------------------------+---------------------------+

11. **Data set name: SRF_LAD2**

> **Description: SOLVD Randomization Form (SRF)**
>
> **Form versions: A, B**
>
> **Number of observations: 6797**
>
> **Visit range: 3**
>
> **Structure: One observation for each ID_SOL**
>
> **Sort order (unique keys): ID_SOL**

+-----------+-----------------------------+---------------------------+
| #         | # Description               | # Modification/Comment    |
|  Variable |                             |                           |
+-----------+-----------------------------+---------------------------+
| RDATE     | Randomization date          | Standard date             |
|           |                             | transformation (resulting |
|           |                             | in value of 0 for all     |
|           |                             | participants)             |
+-----------+-----------------------------+---------------------------+
| SRF1      | Date form completed         | Standard date             |
|           |                             | transformation            |
+-----------+-----------------------------+---------------------------+
| SRF2      | Date of last SOLVD Visit    | Standard date             |
|           | (Visit 2)                   | transformation            |
+-----------+-----------------------------+---------------------------+
| SRF3Z1    | Participant's last name     | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SRF3Z2    | Participant's first name    | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SRF3Z3    | Participant's middle name   | Dropped, personal         |
|           |                             | information               |
+-----------+-----------------------------+---------------------------+
| SRF4      | Initials of person          | Dropped, personal         |
|           | completing this form        | information               |
+-----------+-----------------------------+---------------------------+
| SRF5Z1    | NYHA CHF classification     | Dropped, no information   |
|           | (Ver B)                     | for 50% of participants   |
+-----------+-----------------------------+---------------------------+
| SRF5Z2    | Participant taking          | Dropped, no information   |
|           | digitalis ? (Ver B)         | for 50% of participants   |
+-----------+-----------------------------+---------------------------+
| SRF5Z3    | Is the indication of use of | Dropped, no information   |
|           | digitalis for treatment of  | for 88% of participants   |
|           | supraventricular            |                           |
|           | arrhythmias ? (Ver B)       |                           |
+-----------+-----------------------------+---------------------------+
| SRF5Z4    | Participant currently on    | Dropped, no information   |
|           | diuretic therapy ? (Ver B)  | for 50% of participants   |
+-----------+-----------------------------+---------------------------+
| SRF5Z5    | Is the indication of use of | Dropped, no information   |
|           | diuretic therapy for        | for 85% of participants   |
|           | treatment of CHF ? (Ver B)  |                           |
+-----------+-----------------------------+---------------------------+
| SRF5Z6Z1  | Reason for diuretic         | Dropped, no information   |
|           | therapy: Hypertension (Ver  | for 94% of participants   |
|           | B)                          |                           |
+-----------+-----------------------------+---------------------------+
| SRF5Z62A  | Reason for diuretic         | Dropped, count too low    |
|           | therapy: Peripheral edema   |                           |
|           | -- lymphatic disorders (Ver |                           |
|           | B)                          |                           |
+-----------+-----------------------------+---------------------------+
| SRF5Z62B  | Reason for diuretic         | Dropped, count too low    |
|           | therapy: Peripheral edema   |                           |
|           | -- venous insufficiency     |                           |
|           | (Ver B)                     |                           |
+-----------+-----------------------------+---------------------------+
| SRF5Z62C  | Reason for diuretic         | Dropped, count too low    |
|           | therapy: Peripheral edema   |                           |
|           | -- nifedipine (Ver B)       |                           |
+-----------+-----------------------------+---------------------------+
| SRF5Z62D  | Reason for diuretic         | Dropped, count too low    |
|           | therapy: Peripheral edema   |                           |
|           | -- perimenstrual (Ver B)    |                           |
+-----------+-----------------------------+---------------------------+
| SRF6Z3    | Number of days since Visit  | Top/bottom coding:        |
|           | 2                           |                           |
|           |                             | Values above 21 recoded   |
|           |                             | to 21.                    |
|           |                             |                           |
|           |                             | (Only 1 value (25)        |
|           |                             | affected).                |
+-----------+-----------------------------+---------------------------+
| SRF6Z4    | Adherence                   | Top/bottom coding:        |
|           |                             |                           |
|           |                             | Values below 84 recoded   |
|           |                             | to 84.                    |
|           |                             |                           |
|           |                             | Values above 105 recoded  |
|           |                             | to 105.                   |
+-----------+-----------------------------+---------------------------+