Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 1
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Post-baseline Study Visits Since the actual visit for a subject may not exactly coincide with their targeted visit date, the actual visit date is mapped to the study visit as following. The study day window will be utilized to define study visit for labs, antibody, vital signs and physical measurements collected at office visits. Study Visit Target Day Study Day Week 4 29 16-43 Week 8 57 44-71 Week 12 85 72 to Min (EOS Date, last IP dose date + 84 days) Note: 1. If more than one visit (including unscheduled visits, ie, CPEVENT = ‘UNSCHED’) fall within the same defined window, scheduled visit will be used regardless of the distance from the target day. Unscheduled visit will only be used when there is no scheduled visit in the defined window. The closest visit to the target day among the same type of visit (scheduled vs. unscheduled) will be considered for analysis. If two assessment dates are equidistant from the target date, the latter visit will be considered for analysis. 2. For Country Specific Supplement countries, CSSRS and ECG data are collected at week 2 (target day 14), corresponding to study day 1-28. 3URGXFW $0* &OLQLFDO6WXG\5HSRUW3ULPDU\$QDO\VLV 'DWH $SULO 3DJH 3URGXFW$0* 6WDWLVWLFDO$QDO\VLV3ODQ 'DWH-DQXDU\ 3DJH $SSHQGL[%7HFKQLFDO'HWDLODQG6XSSOHPHQWDO,QIRUPDWLRQ5HJDUGLQJ6WDWLVWLFDO 3URFHGXUHVDQG3URJUDPV &RGH)UDJPHQWV 6HFWLRQ CCI 3URGXFW $0* &OLQLFDO6WXG\5HSRUW3ULPDU\$QDO\VLV 'DWH $SULO 3DJH 3URGXFW$0* 6WDWLVWLFDO$QDO\VLV3ODQ 'DWH-DQXDU\ 3DJH CCI 3URGXFW $0* &OLQLFDO6WXG\5HSRUW3ULPDU\$QDO\VLV 'DWH $SULO 3DJH 3URGXFW$0* 6WDWLVWLFDO$QDO\VLV3ODQ 'DWH-DQXDU\ 3DJH CCI Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 29 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 28 Appendix C. Reference Values/Toxicity Grades Adverse event severity and laboratory parameters are graded based on National Cancer Institute (NCI) Common Toxicity Criteria version 4 or higher, which is available at the following: http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06- 14_QuickReference_5x7.pdf Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 30 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 29 Appendix D. Concomitant Medications Group Medications Beta-blockers BETA BLOCKING AGENTS ADAPROLOL ANTIARRHYTHMIC AGENTS BETA BLOCKING AGENTS BUFETOLOL BUFETOLOL HYDROCHLORIDE DILEVALOL DILEVALOL HYDROCHLORIDE ISAMOLTAN MABUTEROL MABUTEROL HYDROCHLORIDE MOPROLOL MOPROLOL HYDROCHLORIDE NADOXOLOL NADOXOLOL HYDROCHLORIDE NIFENALOL NIFENALOL HYDROCHLORIDE OBERADILOL ALPRENOLOL ALPRENOLOL BENZOATE ALPRENOLOL HYDROCHLORIDE BETA BLOCKING AGENTS, NON-SELECTIVE BETAMED /02298401/ BLOCOTIN /00716001/ BOPINDOLOL BOPINDOLOL FUMARATE BOPINDOLOL MALONATE BUCINDOLOL BUCINDOLOL HYDROCHLORIDE BUFURALOL BUFURALOL HYDROCHLORIDE BUNITROLOL BUNITROLOL HYDROCHLORIDE Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 31 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 30 BUPRANOLOL BUPRANOLOL HYDROCHLORIDE CARAZOLOL CARTEOLOL CARTEOLOL HYDROCHLORIDE CLORANOLOL CLORANOLOL HYDROCHLORIDE CLOTAS PLUS EXAPROLOL EXAPROLOL HYDROCHLORIDE INDENOLOL INDENOLOL HYDROCHLORIDE MEPINDOLOL MEPINDOLOL SULFATE METIPRANOLOL METIPRANOLOL HYDROCHLORIDE NADOLOL NIPRADOLOL OXPRENOLOL OXPRENOLOL HYDROCHLORIDE PENBUTOLOL PENBUTOLOL SULFATE PINDOLOL PRONETALOL PRONETALOL HYDROCHLORIDE PROPRANOLOL PROPRANOLOL HYDROCHLORIDE PROPRANOLOL PHENOBARBITAL SOLOPOSE BETA SOTACOR/ASA SOTALOL SOTALOL HYDROCHLORIDE TENSYN PLUS TERTATOLOL TERTATOLOL HYDROCHLORIDE TILISOLOL Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 32 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 31 TILISOLOL HYDROCHLORIDE TIMOLOL TIMOLOL HEMIHYDRATE TIMOLOL MALEATE TIMOLOL MALEATE, R-ENANTIOMER TIMOLOL MALEATE, S-ENANTIOMER ZEPRO /02777801/ ACEBUTOLOL ACEBUTOLOL HYDROCHLORIDE ATENOLOL ATENOLOL HYDROCHLORIDE BELOC /01739801/ BETA BLOCKING AGENTS, SELECTIVE BETAXOLOL BETAXOLOL HYDROCHLORIDE BEVANTOLOL BEVANTOLOL HYDROCHLORIDE BISOBLOCK PLUS BISOPROLOL BISOPROLOL FUMARATE BUCUMOLOL BUCUMOLOL HYDROCHLORIDE BUTIDRINE CELIPROLOL CELIPROLOL HYDROCHLORIDE DEXNEBIVOLOL DIACETOLOL DIACETOLOL HYDROCHLORIDE EPANOLOL ERAMID ESATENOLOL ESMOLOL ESMOLOL HYDROCHLORIDE LANDIOLOL LANDIOLOL HYDROCHLORIDE LEVONEBIVOLOL Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 33 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 32 METOPROLOL METOPROLOL FUMARATE METOPROLOL SUCCINATE METOPROLOL TARTRATE METOPROLOL W/MORPHINE METPURE ST NEBIVOLOL NEBIVOLOL HYDROCHLORIDE PAFENOLOL PRACTOLOL SELOKEN ZOC/ASA TALINOLOL TOLAMOLOL TOLAMOLOL HYDROCHLORIDE ZOLAT /03453901/ ALPHA AND BETA BLOCKING AGENTS AMINO ACIDS NOS W/CAFFEINE/CARVEDILOL/CHOLINE AMOSULALOL AMOSULALOL HYDROCHLORIDE AROTINOLOL AROTINOLOL HYDROCHLORIDE CARVEDILOL CARVEDILOL HYDROCHLORIDE CARVEDILOL PHOSPHATE HEMIHYDRATE LABETALOL LABETALOL HYDROCHLORIDE MEDROXALOL MEDROXALOL HYDROCHLORIDE PROXODOLOL BETA BLOCKING AGENTS AND THIAZIDES BETA BLOCKING AGENTS, NON-SELECTIVE, AND THIA BETACENTYL CORGARETIC CORINDOCOMB Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 34 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 33 DOCIDRAZIN HIPERDON /00991401/ INDERETIC INDERIDE PRESTYL SOTAZIDE TIMOLIDE TORRAT TRASIDREX TRI-TORRAT VISKAZIDE ATENOLOL W/HYDROCHLOROTHIAZIDE ATPURE-D BELOC-ZOC COMP BETA BLOCKING AGENTS, SELECTIVE, AND THIAZIDE BISELECT /01166101/ BISOPROLOL W/HYDROCHLOROTHIAZIDE /06833601/ CO-BETALOC NEATENOL DIU NEATENOL DIUVAS NEBICARD-H RANEZIDE SECADREX SECTRAZIDE /00774201/ SELOKEN COMP. TRELOC ALPHA AND BETA BLOCKING AGENTS AND THIAZIDES CO-DILATREND NORMOZIDE /00897401/ BETA BLOCKING AGENTS AND OTHER DIURETICS BETA BLOCKING AGENTS, NON-SELECTIVE/90118901/ BETARELIX HIPERDON /00991401/ Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 35 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 34 LASIPRESSIN SANDORETIC SPIROPROP TRASITENSIN TREPRESS VISKALDIX BETA BLOCKING AGENTS, SELECTIVE, AND OTHER DI INDAPAMIDE W/NEBIVOLOL HYDROCHLORIDE LOPRESORETIC NOR-PA SALI-PRENT SELECTURON TEKLO TENORETIC TRI-NORMIN VINICOR D ALPHA AND BETA BLOCKING AGENTS AND OTHER DIUR CARVEDILOL + CLORTALIDONA TRANDIUR BETA BLOCKING AGENTS, THIAZIDES AND OTHER DIU BETA BLOCKING AGENTS, NON-SELECTIVE, THIAZIDE CARDIOTENSIN /01682501/ DOCITEREN DOCITON 80 DYTIDE H MODUCREN BETA BLOCKING AGENTS, SELECTIVE, THIAZIDES AN KALTEN KERLIDEX BETA BLOCKING AGENTS AND VASODILATORS BETA BLOCKING AGENTS, NON-SELECTIVE, AND VASO BETA-INTENSAIN NITRISKEN NITRO-OBSIDAN Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 36 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 35 OXYCARDIN /00391901/ PRIZIDILOL PRIZIDILOL HYDROCHLORIDE PRIZIDILOL HYDROCHLORIDE ANHYDROUS BETA BLOCKING AGENTS, SELECTIVE, AND VASODILA MET XL R METOPROLOL W/RAMIPRIL NEBICARD V STARPRESS R BETA BLOCKING AGENTS AND OTHER ANTIHYPERTENSI BETA BLOCKING AGENTS, NON-SELECTIVE/90119501/ BETADIPRESAN INDUCOR INDUCOR D OBSILAZIN REDUPRESS /03518901/ TRASIPRESSOL TRIMECRYTON AMLODIPINE W/METOPROLOL AMLODIPINE W/NEBIVOLOL AMLONG-A ARBITEL MT ATPURE-SA BELNIF BETA BLOCKING AGENTS, SELECTIVE, AND OTHER AN BETAFIT AM BETAONE AM CARDIF BETA CARDIORETIC A CARVEDIPINA D CILNIDIPINE W/METOPROLOL SUCCINATE CILNIPAR M CONCOR AM Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 37 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 36 CONCORAM FELODIPINE W/METOPROLOL FIXOCARD LOTENSYL AT MET XL AM METONCE AM METOPROLOL W/TELMISARTAN MODILOC NEBI AM NEBICARD-SM NIF-TEN NITRENOL NUSAR-ATN OLSAR M RASOTAN BETA TELISTA MT TONORMA TREDALAT ADAPROLOL ALCON BETAXOLOL AZARGA BAMOSIRAN BEFUNOLOL BEFUNOLOL HYDROCHLORIDE BETA BLOCKING AGENTS BETALOL /03186001/ BETAXOLOL BETAXOLOL HCL W/PILOCARPINE HCL BETAXOLOL HYDROCHLORIDE BETAXOLOL W/PILOCARPINE BLOCANOL /01100601/ BRIMONIDINE TARTRATE W/TIMOLOL BRIMONIDINE W/TIMOLOL Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 38 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 37 CARPILO CARTEOL /00853401/ CARTEOLOL CARTEOLOL HYDROCHLORIDE CARTEOPIL COMBIGAN COSOPT DORZOLAMIDE W/TIMOLOL DORZOPT /06421101/ DUOTRAV ELAZOP GANFORT GLAUTIMOL /06108601/ KRITANTEK OFTENO KRYTANTEK OFTENO LEVOBUNOLOL LEVOBUNOLOL HYDROCHLORIDE METIPRANOLOL METIPRANOLOL HYDROCHLORIDE MOPROLOL MOPROLOL HYDROCHLORIDE NIPRADOLOL NORMOGLAUCON /01482401/ PILOBLOQ PILOFLAX PINDOLOL PROXODOLOL PROXOPHELIN RIPIX TAFLUPROST W/TIMOLOL MALEATE TIMED TIMOLO TIMOLOL Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 39 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 38 TIMOLOL HEMIHYDRATE TIMOLOL MALEATE TIMOLOL MALEATE, R-ENANTIOMER TIMOLOL MALEATE, S-ENANTIOMER TIMPILO VISTAGAN /00844001/ XALACAR-T XALACOM Nitrates ADOCOR /01266201/ ANGIOCARDYL N ANGOR ASPITRATE G BIDIL CAFINITRINA /00702101/ CAFINITRINA /07893501/ CAFINITRINA RETARD CARDIACAP A CARDIOSEDANTOL CEFAVORA COR /08009401/ CONVALLARIA MAJALIS W/GLYCERYL TRINITRATE/LEV CORANGIL DILCORAN /00119101/ ERITRITYL TETRANITRATE ERYTHROMIN /01950501/ EUCARDIN GLYCERYL TRINITRATE GLYCERYL TRINITRATE, COMBINATIONS GOVIL IMAZIN XL ISO-NITROLINGUAL ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE W/SODIUM CHLORIDE ISOSORBIDE DINITRATE, COMBINATIONS ISOSORBIDE MONONITRATE Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 40 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 39 KORDILAT MANNITOL HEXANITRATE METHYLPROPYLPROPANEDIOL DINITRATE MYANGIN MYOCARDON /00091601/ MYOCARDON /02403401/ MYOCARDON /03439401/ MYOCORIL NATIROSE /01832701/ NEO-AKTAL NITRANGIN COMPOSITUM NITRAPAMIL NITRIC OXIDE NITRO-CRATAEGUTT NITRODURAT NITROGLIN NITROGLYCERIN COMP. NITROPENT COMP. NITROTHESAL NITROUS ETHER SPIRIT NUNZANGIL ORGANIC NITRATES PENTAERITHRITYL TETRANITRATE PENTANEURAL PENTOXYLON PENTRINITROL PENTRIUM PROPATYLNITRATE SEDA-ILDAMEN SORBANGIL COMP. SPASMOCOR STENODILATE STENOPTIN TENITRAMINE THEOPENTRIT THEOPENTRIT PAPAV Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 41 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 40 TRINITRINE CAFFEINE TROLNITRATE TROLNITRATE PHOSPHATE VISANOCOR VISANOCOR N VERAPAMIL Calcium channel VERAPAMIL HYDROCHLORIDE blockers ISOPTIN S TALUVIAN /00149301/ LIDOFLAZINE PERHEXILINE PERHEXILINE MALEATE GRADULON FENDILINE FENDILINE HYDROCHLORIDE NIFEDIPINE DILTIAZEM DILTIAZEM HYDROCHLORIDE DILTIAZEM MALATE DIGO-SENSIT STENOPTIN CORDICHIN ELTHON /00603601/ NICARDIPINE NICARDIPINE HYDROCHLORIDE GALLOPAMIL GALLOPAMIL HYDROCHLORIDE FELODIPINE ISRADIPINE TIAPAMIL SALI-ADALAT BEPRIDIL BEPRIDIL HYDROCHLORIDE MONOHYDRATE NITRENDIPINE TREDALAT NISOLDIPINE NIF-TEN BELNIF NIMODIPINE VERATIDE Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 42 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 41 OXODIPINE AMLODIPINE AMLODIPINE BESILATE AMLODIPINE MALEATE AMLODIPINE MESILATE AMLODIPINE CAMSILATE AMLODIPINE OROTATE S AMLODIPINE NICOTINATE AMLODIPINE ADIPATE NILVADIPINE MANIDIPINE MANIDIPINE HYDROCHLORIDE LACIDIPINE BENIDIPINE BENIDIPINE HYDROCHLORIDE MODILOC EFONIDIPINE EFONIDIPINE HYDROCHLORIDE SALOPTASIN BARNIDIPINE BARNIDIPINE HYDROCHLORIDE UDRAMIL MIBEFRADIL MIBEFRADIL HYDROCHLORIDE LEXXEL TECZEM /01366001/ LERCANIDIPINE LERCANIDIPINE HYDROCHLORIDE CILNIDIPINE VERACAPT UNIMAX ADIZEM-XL PLUS ANIPAMIL TILDIAZIDE OCADRIK /01507301/ AZELNIDIPINE ENEAS NIMOREAGIN /01616501/ AMLODIPINE W/BENAZEPRIL AMLODIPINE BESYLATE W/BENAZEPRIL AMLODIPINE W/VALSARTAN Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 43 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 42 AMLODIPINE W/HYDROCHLOROTHIAZIDE AMLONG-A CADUET ARANIDIPINE SINERGEN HYDROCHLOROTHIAZIDE W/VERAPAMIL LOTAR /02225901/ AMLOPRES L RIODIPINE DIOVAN AMLO MET XL AM TONORMA FIXOCARD LOTRIX /03460001/ NIMOSOMAZINA REDUPRESS /03518901/ NAPRIX A ASOMEX-D CARDIF BETA LOTENSYL AT ATPURE-SA NEBICARD-SM ACEDIP CLEVIDIPINE ANTROLIN CARDIORETIC A NITRENOL ETIPRESS-D MAXIDIPIN DIU NIFEDIP D CARVEDIPINA D INDUCOR INDUCOR D BETAONE AM AZOR /06230801/ AMLOZAAR-H TWYNSTA TELSAR-A DIOVAN TRIPLE OROSPREVENT COVERAM Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 44 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 43 NEMOCEBRAL PLUS LEVAMLODIPINE LEVAMLODIPINE BESILATE LEVAMLODIPINE MALATE LEVAMLODIPINE MALEATE FELODIPINE W/METOPROLOL NIFEDIPINE W/TELMISARTAN PONTUC DIRONORM COZAAR XQ BENITEC A /06541301/ OLMESAFE AM CONCOR AM CANDESAR A AMLODIPINE W/ATORVASTATIN TRIBENZOR ATACAND DUO AMLODIPINE MALEATE W/BENAZEPRIL HYDROCHLORIDE RASILEZ AMLO AMTAS PRP FLORDIPINE NIGULDIPINE NORVERAPAMIL AZIDOPINE IGANIDIPINE AMLODIPINE W/BENAZEPRIL HYDROCHLORIDE VIVACE /06864501/ FENSARTAN UNIMAX AMTURNIDE AVOTIN AZELNIDIPINE W/OLMESARTAN MEDOXOMIL AMLODIPINE BESILATE W/ATORVASTATIN CALCIUM TR MOXOVAS A OLMAT AMH TEKAMLO /07156301/ AMLODIPINE W/HYDROCHLOROTHIAZIDE/VALSARTAN NATRILAM BETAFIT AM CILACAR T Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 45 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 44 MODLIP AM NEBI AM DILVAS AM R PRIL AM AMLODAC D TELMICHEK AH RASITRIO DUPLECOR PERINDOPRIL ARG/AMLODIPINE FISHER CONCORAM AMLATOR TAH ENALAPRIL W/NITRENDIPINE APROVASC COROVAL B ZANERIL ENALAPRIL W/LERCANIDIPINE AMLODIPINE W/OLMESARTAN ANOBLISS ASOMEX TM RAMI ASOMEX CILNIPAR M ASOMEX LTH METONCE AM ROSUCOR PLUS AMLODIPINE W/NEBIVOLOL AMLODIPINE W/INDAPAMIDE/PERINDOPRIL LERCANIDIPINE HYDROCHLORIDE W/VALSARTAN LEVAMLODIPINE BESILATE W/VALSARTAN AMLODIPINE W/CHLORTALIDONE/LOSARTAN POTASSIUM CILNIDIPINE W/OLMESARTAN MEDOXOMIL AMLODIPINE OROTATE W/VALSARTAN HYDROCHLOROTHIAZIDE W/LEVAMLODIPINE BESILATE AMLODIPINE MESILATE W/HYDROCHLOROTHIAZIDE/VAL AMLODIPINE W/CHLORTALIDONE/OLMESARTAN MEDOXOM AMLODIPINE W/CHLORTALIDONE/TELMISARTAN AMLODIPINE BESILATE W/INDAPAMIDE/PE/08715301/ AMLODIPINE BESILATE W/PERINDOPRIL TOSILATE AMLODIPINE BESILATE W/INDAPAMIDE/PE/08717501/ Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 46 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 45 CILNIDIPINE W/VALSARTAN AMLODIPINE BESILATE W/AZILSARTAN ATORVASTATIN CALCIUM W/LEVAMLODIPINE BESILATE CILNIDIPINE W/METOPROLOL SUCCINATE AMLODIPINE W/METOPROLOL AMLODIPINE BESILATE W/CANDESARTAN CILEXETIL/H AMLODIPINE W/LISINOPRIL/ROSUVASTATIN AMLODIPINE W/ROSUVASTATIN AMLODIPINE ADIPATE W/VALSARTAN AMLODIPINE W/CLOPIDOGREL BISULFATE CHLORTALIDONE W/CILNIDIPINE/TELMISARTAN AMLODIPINE OROTATE W/OLMESARTAN MEDOXOMIL CALCIUM CHANNEL BLOCKERS SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINL DIHYDROPYRIDINE DERIVATIVES SELECTIVE CALCIUM CHANNEL BLOCKERS WITH DIREC PHENYLALKYLAMINE DERIVATIVES BENZOTHIAZEPINE DERIVATIVES NON-SELECTIVE CALCIUM CHANNEL BLOCKERS Ranolazine Ranolazine CAPTOPRIL ACE inhibitors ENALAPRIL ENALAPRIL MALEATE CAPOZIDE PERINDOPRIL PERINDOPRIL ERBUMINE PERINDOPRIL ARGININE PERINDOPRIL TOSILATE QUINAPRIL QUINAPRIL HYDROCHLORIDE CILAZAPRIL CILAZAPRIL MONOHYDRATE RAMIPRIL LISINOPRIL LISINOPRIL DIHYDRATE VASERETIC SPIRAPRIL SPIRAPRIL HYDROCHLORIDE Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 47 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 46 BENAZEPRIL BENAZEPRIL HYDROCHLORIDE FOSINOPRIL FOSINOPRIL SODIUM ENALAPRILAT ZOFENOPRIL ZOFENOPRIL CALCIUM ALACEPRIL DELAPRIL DELAPRIL HYDROCHLORIDE GEZOR TRANDOLAPRIL CIBADREX SALUTEC ARELIX ACE DYNORM PLUS QUINAPRILAT QUINAPRILAT HYDRATE TEMOCAPRIL TEMOCAPRIL HYDROCHLORIDE IMIDAPRIL IMIDAPRIL HYDROCHLORIDE MOEXIPRIL MOEXIPRIL HYDROCHLORIDE UDRAMIL ELIDIUR LEXXEL TECZEM /01366001/ VERACAPT LASITACE DELAPRIDE PRIMOX PLUS UNIMAX BI PREDONIUM BENAZEPRILAT PENTOPRIL IDRAPRIL MOVELTIPRIL CERONAPRIL TRANDOLAPRILAT UTIBAPRIL ZABICIPRIL Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 48 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 47 LIBENZAPRIL DINAPRES OCADRIK /01507301/ ENEAS CARACE PLUS /01613901/ AMLODIPINE W/BENAZEPRIL AMLODIPINE BESYLATE W/BENAZEPRIL ALENDRONATE SODIUM W/QUINAPRIL HYDROCHLORIDE SINERGEN AMLOPRES L LORAM-H ENZIX LOTRIX /03460001/ ARBITACE ORAS /03528201/ TERAM NAPRIX A ACEDIP M 100240 VASCORIDE CARDIO-PRES D CARSIPRIL D RAMICAR D CVPILL NORMATEN /06267401/ ATOCOR-R MODLIP-CAD OLMY-R ADPACE BIFRIL PLUS PERINDO COMBI COVERAM PRETERAX ARGININE ZESTORETIC INDAPAMIDE W/PERINDOPRIL HYDROCHLOROTHIAZIDE W/QUINAPRIL FOSINOPRIL W/HYDROCHLOROTHIAZIDE ENAP-HL /06436201/ CAPTOPRIL W/ENALAPRIL DIRONORM POLYCAP ZOPRANOL PLUS Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 49 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 48 AMLODIPINE MALEATE W/BENAZEPRIL HYDROCHLORIDE AMTAS PRP CILAZAPRIL MONOHYDRATE W/HYDROCHLOROTHIAZIDE GEMOPATRILAT HYDROCHLOROTHIAZIDE W/MOEXIPRIL FASIDOTRIL UTIBAPRILAT MOEXIPRILAT MOEXIPRILAT HYDROCHLORIDE OMAPATRILAT AMLODIPINE W/BENAZEPRIL HYDROCHLORIDE BENAZEPRIL W/HYDROCHLOROTHIAZIDE VIVACE /06864501/ CAPTRAL ASA RAMEY D STARPRESS R DILVAS AM R PRIL AM VALZAAR R TERAM H METPURE AR PERINDOPRIL ARG/AMLODIPINE FISHER LOTRIAL VAS ENALAPRIL W/NITRENDIPINE SINCRONIUM /07912401/ COROVAL B ZANERIL ENALAPRIL W/LERCANIDIPINE RAMITORVA METOZ R MET XL R RAMI ASOMEX PERINDOPRIL TOSILATE/ INDAPAMIDE METOPROLOL W/RAMIPRIL SAMPATRILAT AMLODIPINE W/INDAPAMIDE/PERINDOPRIL GLIMEPIRIDE W/METFORMIN HYDROCHLORIDE/RAMIPRI ATORVASTATIN CALCIUM W/GLIMEPIRIDE//08698201/ AMLODIPINE BESILATE W/INDAPAMIDE/PE/08715301/ AMLODIPINE BESILATE W/PERINDOPRIL TOSILATE Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 50 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 49 AMLODIPINE BESILATE W/INDAPAMIDE/PE/08717501/ AMLODIPINE W/LISINOPRIL/ROSUVASTATIN TEMOCAPRILAT INDAPAMIDE HEMIHYDRATE W/PERINDOPRIL ARGININE ACE INHIBITORS, PLAIN ACE INHIBITORS, COMBINATIONS ACE INHIBITORS AND CALCIUM CHANNEL BLOCKERS ACE INHIBITORS LOSARTAN Angiotensin LOSARTAN POTASSIUM receptor blockers HYZAAR TASOSARTAN SAPRISARTAN SAPRISARTAN POTASSIUM VALSARTAN IRBESARTAN IRBESARTAN HYDROCHLORIDE CO-DIOVAN EPROSARTAN EPROSARTAN MESILATE CANDESARTAN CANDESARTAN CILEXETIL KARVEA HCT BLOPRESS PLUS TELMISARTAN HYDROCHLOROTHIAZIDE W/LOSARTAN AMLODIPINE W/VALSARTAN OLMESARTAN OLMESARTAN MEDOXOMIL BENICAR HCT CANDESARTAN W/HYDROCHLOROTHIAZIDE LOTAR /02225901/ DIOVAN AMLO LORAM-H NUSAR-ATN ARBITACE ORAS /03528201/ TERAM DIOCOMB SI AZOR /06230801/ AMLOZAAR-H TWYNSTA TELSAR-A DIOVAN TRIPLE OLMY-R LOSAR BETA-H ADPACE Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 51 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 50 VALTURNA EMBUSARTAN PRITORPLUS EMESTAR PLUS NIFEDIPINE W/TELMISARTAN HYDROCHLOROTHIAZIDE W/OLMESARTAN COZAAR XQ PLEOTOR T BENITEC A /06541301/ OLMESAFE AM CANDESAR A TRIBENZOR ATACAND DUO ABITESARTAN RIPISARTAN AZILSARTAN AZILSARTAN MEDOXOMIL AZILSARTAN KAMEDOXOMIL POMISARTAN PRATOSARTAN FENSARTAN UNIMAX OLSAR M AZELNIDIPINE W/OLMESARTAN MEDOXOMIL OLMAT AMH AMLODIPINE W/HYDROCHLOROTHIAZIDE/VALSARTAN CO IRABEL CILACAR T INDITEL D ZIVAST L VALZAAR R NEBICARD V TERAM H RASOTAN BETA TELISTA MT TELMICHEK AH EDARBYCLOR FIMASARTAN FIMASARTAN POTASSIUM TRIHYDRATE TELROSE CTD L ARBITEL MT TAH APROVASC AMLODIPINE W/OLMESARTAN ERITEL CH OLMESAT ID ALISKIREN W/VALSARTAN METOZ L METOPROLOL W/TELMISARTAN Product: AMG 334 Clinical Study Report: 20140254 Primary Analysis Date: 13 April 2017 Page 52 Product: AMG 334 Statistical Analysis Plan: 20140254 Date: 07 January 2017 Page 51 ASOMEX TM OLMESAR AV ASOMEX LTH IRBESARTAN W/TRICHLORMETHIAZIDE FIMASARTAN POTASSIUM TRIHYDRATE W/HYDROCHLORO LERCANIDIPINE HYDROCHLORIDE W/VALSARTAN LEVAMLODIPINE BESILATE W/VALSARTAN AMLODIPINE W/CHLORTALIDONE/LOSARTAN POTASSIUM CHLORTALIDONE W/OLMESARTAN MEDOXOMIL CILNIDIPINE W/OLMESARTAN MEDOXOMIL AMLODIPINE OROTATE W/VALSARTAN AMLODIPINE MESILATE W/HYDROCHLOROTHIAZIDE/VAL ATORVASTATIN CALCIUM W/IRBESARTAN AMLODIPINE W/CHLORTALIDONE/OLMESARTAN MEDOXOM AMLODIPINE W/CHLORTALIDONE/TELMISARTAN OLMESARTAN MEDOXOMIL W/ROSUVASTATIN CALCIUM CILNIDIPINE W/VALSARTAN ROSUVASTATIN CALCIUM W/VALSARTAN AMLODIPINE BESILATE W/AZILSARTAN AMLODIPINE BESILATE W/CANDESARTAN CILEXETIL/H AMLODIPINE ADIPATE W/VALSARTAN CHLORTALIDONE W/CILNIDIPINE/TELMISARTAN AMLODIPINE OROTATE W/OLMESARTAN MEDOXOMIL SACUBITRIL W/VALSARTAN ANGIOTENSIN II ANTAGONISTS, PLAIN ANGIOTENSIN II ANTAGONISTS, COMBINATIONS ANGIOTENSIN II ANTAGONISTS AND CALCIUM CHANNE