appendix c hfsa guidelines recommendations
hfsa guidelines criteria for nyha

| CLASS 1   | No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea.                                                     |
|-----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CLASS 2   | Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation or dyspnea.                                   |
| CLASS 3   | Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation or dyspnea.                                      |
| CLASS 4   | Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. |
appendix c hfsa guidelines recommendations
hfsa guidelines glossary of clinical

| Glossary of Clinical Trials                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |                                                                                     |         |    |          |    |      |    |          |        |      |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------|----|----------|----|------|----|----------|--------|------|
| AVID                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | Antiarrhythmics Versus Implantable Defibrillators                                   |         |    |          |    |      |    |          |        |      |
| BEST                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | Beta-blocker Evaluation of Survival Trial                                           |         |    |          |    |      |    |          |        |      |
| CAMIAT                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | Canadian Amiodarone Myocardial Infarction Arrhythmia Trial CAPRIE                   |         |    |          |    |      |    |          |        |      |
| Clopidogrel                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | vs                                                                                  | Aspirin | in | Patients | at | Risk | of | Ischemic | Events | CASH |
| Cardiac Arrest Study Hamburg CHF-STAT Congestive Heart Failure-Survival Trial of Antiarrhythmic Therapy CHARM Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity CIBIS Cardiac Insufficiency BIsoprolol Study CIBIS II Cardiac Insufficiency Bisoprolol Study II CIDS Canadian Implantable Defibrillator Study COMET Carvedilol or Metoprolol European Trial CONSENSUS Cooperative North Scandinavian Enalapril Survival Study CONSENSUS II Cooperative New Scandinavian Enalapril Survival Study II COPERNICUS Carvedilol Prospective Randomized Cumulative Survival Trial DEFINITE Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation DIAMOND Danish Investigation of Arrhythmia and Mortality on Dofetilide DIG Digitalis Investigation Group ELITE Evaluation of Losartan In The Elderly ELITE II Losartan Heart Failure Survival Study - ELITE II EMIAT Infarction Amiodarone Trial GESICA Grupo de Estudio de Sobrevida en Insuficiencia Cardiaca en Argentina GUSTO 1 Global Utilization of Streptokinase and TPA for Occluded coronary arteries MADIT Multicenter Automatic Defibrillator Implantation Trial MADITII Multicenter Automatic Defibrillator Implantation Trial II Metoprolol in Dilated Cardiomyopathy trial MERIT-HF Metoprolol CR/XL Randomized Intervention Trial in Heart Failure MOCHA Multicenter Oral Carvedilol in Heart-failure Assessment MTT Myocarditis Treatment Trial OPTIMALL Optimal Therapy in Myocardial Infarction with the Angiotensin II Antagonist Losartan PRECISE Prospective Randomized Evaluation of Carvedilol In Symptoms and Exercise PROVED Prospective Randomized study Of Ventricular failure and the Efficacy of Digoxin |                                                                                     |         |    |          |    |      |    |          |        |      |
| RADIANCE                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | Randomized Assessment of Digoxin on Inhibitors of the Angiotensin Converting Enzyme |         |    |          |    |      |    |          |        |      |
| RALES                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | Randomized Aldactone Evaluation Study                                               | 77      |    |          |    |      |    |          |        |      |  
77  
| RESOLVD   | Randomized Evaluation of Strategies for Left Ventricular Dysfunction                                             |
|-----------|------------------------------------------------------------------------------------------------------------------|
| SAVE      | Survival And Ventricular Enlargement                                                                             |
| SCD-HeFT  | Sudden Cardiac Death in Heart Failure: Trial of prophylactic amiodarone versus implantable defibrillator therapy |
| SOLVD     | Studies Of Left Ventricular Dysfunction                                                                          |
| SWORD     | Survival With Oral D-sotalol                                                                                     |
| ValHeFT   | Valsartan Heart Failure Trial                                                                                    |
| VALIANT   | Valsartan in Acute Myocardial Infarction                                                                         |
appendix c hfsa guidelines recommendations
appendix d

Safety Reporting Fax Cover Sheet  
  
  
 Genentech Supported Research  
AE / SAE FAX No: (650) 225-4682 Alternate Fax No: (650) 225-5288  
| Genentech Study Number Principal Investigator Site Name Reporter name Reporter Telephone # Reporter Fax #   |
|-------------------------------------------------------------------------------------------------------------|  
Initial Report Date [DD] / [MON] / [YY] Follow-up Report Date [DD] / [MON] / [YY]  
SAE or Safety Reporting questions, contact Genentech Safety: (888) 835-2555 PLEASE PLACE SAFETY REPORT BEHIND THIS COVER SHEET  
| Subject Initials                             | [ ] - [ ] - [ ]   |
|----------------------------------------------|-------------------|
| (Enter a dash if patient has no middle name) |                   |