natgillin/translations-raw huggingface dataset:
Study CAC-91-10-10, (Investigation in the pathogenesis of liver disease in patients with inborn errors of bile acid metabolism) was conducted from 1992-2009 to evaluate the therapeutic efficacy and safety of cholic acid to treat patients with identified inborn errors of bile acid metabolism.
Med letoma 1992 in 2009 so izvedli študijo CAC-91-10-10 (Preučevanje patogeneze jetrne bolezni pri bolnikih s prirojenimi okvarami presnove žolčnih kislin – Investigation in the pathogenesis of liver disease in patients with inborn errors of bile acid metabolism), s katero so ocenili terapevtsko učinkovitost in varnost holne kisline pri zdravljenju bolnikov z ugotovljenimi prirojenimi okvarami presnove žolčnih kislin.
Study CLDT600A2303 - Clinical results over 208 weeks
Študija CLDT600A2303 - klinični rezultati v 208 tednih zdravljenja
Study CLDT600A2303 included HBeAg-positive patients from studies NV-02B-007 (GLOBE) or NV-02B-015 for off-treatment follow up.
V študijo CLDT600A2303 so vključili HBeAg-pozitivne bolnike iz študij NV-02B-007 (GLOBE) ali NV-02B-015 in spremljali njihovo stanje po zaključku zdravljenja.
Study CLDT600ACN04E1 - Impact of treatment on liver histology
Študija CLDT600ACN04E1 - vpliv zdravljenja na histološko zgradbo jeter
Study Cohorts
Študijske kohorte
Study conducted in HIV infected
Študija, izvedena pri bolnikih,
Study conducted in patients with chronic HCV infection
Študija, izvedena pri bolnikih s
Study D1050229
Študija D1050229
Study D1050231
Študija D1050231
Study D1050233
Študija D1050233
Study D2301 (FREEDOMS) was a 2- year placebo-controlled clinical study in 854 patients treated with fingolimod (placebo: 418).
Študija D2301 (FREEDOMS) je bila 2-letna s placebom kontrolirana klinična študija z 854 bolniki, ki so prejemali fingolimod (placebo je prejemalo 418 bolnikov).
Study D2309 (FREEDOMS II) was a 2-year placebo-controlled clinical study in 728 multiple sclerosis patients treated with fingolimod (placebo: 355).
Študija D2309 (FREEDOMS II) je bila 2-letna s placebom kontrolirana klinična študija pri 728 bolnikih z multiplo sklerozo, ki so prejemali fingolimod (placebo pa je prejemalo 355 bolnikov).
Study D9901 was a randomised, double-blind, controlled, multicentre trial in patients with metastatic castrate resistant prostate cancer and no cancer-related pain.
Študija D9901 je bilo randomizirano, dvojno slepo, kontrolirano, multicentrično preskušanje pri bolnikih z metastatskim, na kastracijo odpornim rakom prostate brez bolečin, povezanih z rakom.
Study data indicate that Asian patients may be more susceptible to liver function test abnormalities - 3.2% (194/5995) of Asian patients and 1.8% (100/5641) of Caucasian patients.
Podatki iz študije kažejo, da so bolniki azijskega porekla bolj dovzetni za nenormalnosti v testih jetrnih funkcij: 3,2 % (194/5995) bolnikov azijskega porekla in 1,8 % (100/5641) bolnikov kavkaškega porekla.
Study Day 3* (n=57)
Dan 3* (n=57)
Study E3200 used a 5 mg/kg/week equivalent dose of bevacizumab in bevacizumab-naïve patients, while study ML18147 used a 2.5 mg/kg/week equivalent dose of bevacizumab in bevacizumab- pretreated patients.
V študiji E3200 so uporabljali bevacizumab pri bolnikih, ki ga še niso prejemali, v odmerku, ekvivalentnem 5 mg/kg/teden, medtem, ko so v študiji ML18147 uporabili bevacizumab pri bolnikih, ki so se z njim že zdravili, v odmerku, ekvivalentnem 2,5 mg/kg/teden.
Study ENB-002-08/ENB-003-08
Študija ENB-002-08/ENB-003-08
Study ENB-002-08/ENB-003-08 was an open-label, non-randomised, non-controlled study.
Študija ENB-002-08/ENB-003-08 je bila odprta, nerandomizirana, nekontrolirana študija.
Study ENB-006-09/ENB-008-10 was an open-label, non-randomised study.
Študija ENB-006-09/ENB-008-10 je bila odprta, nerandomizirana študija.
Study endpoint
Opazovani dogodek v študiji
Study endpoints included overall survival, progression-free survival (PFS), response rate, duration of response, time to deterioration of lung cancer-related symptoms (cough, dyspnoea and pain), and safety.
Cilji preskušanja so bili celokupno preživetje (OS, overall survival), preživetje brez napredovanja bolezni (PFS, progression-free survival), odgovor na zdravljenje, trajanje odgovora, čas do poslabšanja simptomov, povezanih z rakom pljuč (kašelj, dispneja in bolečina) in varnost.
Study endpoints included overall survival, progression-free survival (PFS), response rate, duration of response, time to deterioration of lung cancer-related symptoms (cough, dyspnoea and pain), and safety.
Cilji preskušanja so bili celokupno preživetje (OS, overall survival), preživetje brez napredovanja bolezni (PFS, progression-free survival), odgovor na zdravljenje, trajanje odgovora, čas do poslabšanja simptomov, povezanih z rakom pljuč (kašelj, dispneja in bolečina), in varnost.
Study FVF2587g (ANCHOR)
študija FVF2587g (ANCHOR)
Study G2301 was a randomised, double-blind, placebo-controlled withdrawal study of flare prevention by Ilaris.
Študija G2301 je bila randomizirana, dvojno slepa, s placebom kontrolirana študija opuščanja zdravljenja ob uporabi zdravila Ilaris za preprečevanje zagona bolezni.
Study G2305 was a randomised, double-blind, placebo-controlled, 4-week study assessing the short- term efficacy of Ilaris in 84 patients randomised to receive a single dose of 4 mg/kg (up to 300 mg) Ilaris or placebo.
Študija G2305 je bila randomizirana, dvojno slepa, s placebom kontrolirana 4-tedenska študija, v kateri so ocenjevali kratkoročno učinkovitost zdravila Ilaris pri 84 bolnikih, ki so jih randomizirali tako, da so prejeli enkraten odmerek 4 mg/kg (največ 300 mg) zdravila Ilaris ali placebo.
Study Group
Preučevana
Study GS-US-264-0106: Of the 469 emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) -treated patients (317 patients who switched at baseline and 152 patients who switched at Week 24).
Študija GS-US-264-0106: od 469 bolnikov, ki so se zdravili z emtricitabinom/rilpivirinom/dizoproksiltenofovirat fumaratom (FTC/RPV/TDF) (317 bolnikov prešlo na nov režim na začetku, 152 bolnikov pa v 24. tednu).
Study GS-US-264-0106: The efficacy and safety of switching from a ritonavir-boosted PI in combination with two NRTIs to FTC/RPV/TDF was evaluated in a randomised, open-label study in virologically suppressed HIV-1 infected adults.
Študija GS-US-264-0106: Učinkovitost in varnost prehoda z zaviralca proteaze, okrepljenega z ritonavirjem, v kombinaciji z dvema NRTI, na FTC/RPV/TDF so ocenili z randomizirano, odprto študijo pri odraslih z virološko supresijo, okuženih z virusom HIV-1.
Study GS-US-264-0111: Through Week 48, no emergent resistance developed among patients that switched to FTC/RPV/TDF from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) (0 of 49 patients).
Študija GS-US-264-0111: Do konca 48. tedna se rezistenca ni razvila med bolniki, ki so prešli na zdravljenje z FTC/RPV/TDF z efavirenza, emtricitabina in dizoproksiltenofovir fumarata (EFV/FTC/TDF) (0 od 49 bolnikov).
Study GS-US-264-0111: Through week 48, no emergent resistance developed in the 2 patients that failed virologically among patients that switched to Eviplera from efavirenz/emtricitabine/tenofovir disoproxil (0 of 49 patients).
Študija GS-US-264-0111: Do konca 48. tedna se rezistenca, nastala med zdravljenjem, ni razvila pri 2 bolnikih, ki sta imela virološki neuspeh, med bolniki, ki so prešli na zdravljenje z zdravilom Eviplera z efavirenza/emtricitabina/dizoproksiltenofovirja (0 od 49 bolnikov).
Study HPC2014 N = 43
študija HPC2014 N = 43
Study HPC3008
Študija HPC3008
Study HPC3021 N = 40
študija HPC3021 N = 40
Study HS-I (PIONEER I) evaluated 307 patients with 2 treatment periods.
Študija pri psoriazi I (REVEAL) je ocenila 1212 bolnikov v treh obdobjih zdravljenja.
Study I compared the efficacy of each of 2 prophylactic treatment regimens (fixed weekly interval and individualised interval) to on demand treatment.
V študiji I so primerjali učinkovitost obeh profilaktičnih režimov zdravljenja (fiksni tedenski interval in individualizirani interval) z zdravljenjem po potrebi.
Study I compared the efficacy of each of 2 prophylactic treatment regimens (individualised and weekly) to on demand treatment.
V študiji I so primerjali učinkovitost obeh profilaktičnih režimov zdravljenja (individualiziranega in tedenskega) z zdravljenjem na zahtevo.
Study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were  18 years old, had failed therapy with at least one disease-modifying, anti rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Raziskava I je ocenila 271 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih  18 let, pri katerih zdravljenje z vsaj enim imunomodulirajočim antirevmatičnim zdravilom ni bilo uspešno, pri katerih metotreksat v odmerkih od 12,5 do 25 mg (10 mg, če so bili intolerantni za metotreksat) vsak teden ni bil dovolj učinkovit in pri katerih je odmerek metotreksata od 10 do 25 mg ostal stalen vsak teden.
Study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were  18 years old, had failed therapy with at least one disease-modifying, anti rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Raziskava I je ocenila 271 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih  18 let, pri katerih zdravljenje z vsaj enim imunomodulirajočim antirevmatičnim zdravilom ni bilo uspešno, pri katerih metotreksat v odmerkih od 12,5 do 25 mg (10 mg, če so bili intolerantni za metotreksat) vsak teden ni bil dovolj učinkovit in pri katerih je odmerek od 10 do 25 mg metotreksata ostal stalen vsak teden.
Study I evaluated 673 patients who had not been treated with MTX within six months prior to randomisation and who had not discontinued previous MTX treatment as a result of clinically important toxic effects or lack of response.
Študija I je ocenila 673 bolnikov, ki 6 mesecev pred randomizacijo niso dobivali metotreksata, predhodnega zdravljenja z metotreksatom pa niso prekinili zaradi klinično pomembnih toksičnih učinkov ali nezadostnega odziva.
Study I patients were randomized to receive abatacept 2 or 10 mg/kg or placebo for 12 months.
V študiji I so bili bolniki za 12 mesecev randomizirani na abatacept v odmerku 2 ali 10 mg/kg ali placebo.
Study I*
Študija I
Study I: Daily On time (h)
Študija I: Dnevno obdobje ‘ON’ (ure)
Study Ia**
Raziskava Ia
Study II enrolled a total of 30 previously treated male pediatric patients with severe hemophilia B (≤ 2% endogenous FIX activity).
V študijo II je bilo skupaj vključenih 30 predhodno zdravljenih pediatričnih bolnikov moškega spola s hudo hemofilijo B (≤ 2 % endogene aktivnosti FIX).
Study II enrolled a total of 71 previously treated male paediatric patients with severe haemophilia A. Of the 71 enrolled subjects, 69 received at least 1 dose of ELOCTA and were evaluable for efficacy.
V študijo II je bilo skupaj vključenih 71 predhodno zdravljenih pediatričnih bolnikov moškega spola s hudo hemofilijo A. Med 71 vključenimi osebami jih je 69 prejelo vsaj 1 odmerek zdravila ELOCTA in pri njih je bilo mogoče oceniti učinkovitost.
Study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were  18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
Raziskava II je ocenila 544 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih  18 let, pri katerih zdravljenje z vsaj enim imunomodulirajočim antirevmatičnim zdravilom ni bilo uspešno.
Study II LITHE
Študija II LITHE
Study II, a two year study with planned analyses at week 24, week 52 and week 104, evaluated 1,196 patients who had an inadequate clinical response to MTX.
Študija II je bila dveletna študija z načrtovano analizo v 24., 52. ter 104. tednu, ocenila je 1196 bolnikov z nezadostnim kliničnim odzivom na metotreksat.
Study II, III, IV, and VI patients were randomized to receive a fixed dose approximating 10 mg/kg of abatacept or placebo for 12 (Studies II, IV, and VI) or 6 months (Study III).
V študijah II, III, IV in VI so bili bolniki randomizirani tako, da so 12 mesecev (študije II, IV in VI) ali 6 mesecev (študija III) prejemali fiksni odmerek približno 10 mg/kg abatacepta ali placeba.
Study II: Proportion of daily On time (%)
Študija II: Delež dnevnega obdobja ‘ON’ (%)
Study IIa**
Raziskava IIa
Study III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
V študijah III in V je bila dodatna primarna končna točka po 52 tednih upočasnitev napredovanja bolezni (ugotovljena z izvidi
Study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were  18 years old, had insufficient efficacy to methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate- intolerant) every week and whose methotrexate dose remained constant at 12.5 to 25 mg every week.
Raziskava III je ocenila 619 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih  18 let, pri katerih metotreksat v odmerkih od 12,5 do 25 mg (10 mg, če so bili intolerantni za metotreksat) vsak teden ni bil dovolj učinkovit in pri katerih je odmerek metotreksata ostal stalen od 12,5 do 25 mg vsak teden.
Study III OPTION
Študija III OPTION
Study IIIa**
Raziskava IIIa
Study in animals has shown effects on semen parameters, without a significant impact on reproductive performance in males and reduction on the percentage of live foetuses in treated females (see section 5.3).
V študijah na živalih so ugotovili učinke na parametre sperme, brez pomembnega vpliva na sposobnost razmnoževanja pri samcih, in zmanjšanje odstotka živih plodov pri samicah, ki so jim dajali zdravilo (glejte poglavje 5.3).
Study in children/adolescents aged 1 – 18 years with de novo ALL
Študija pri otrocih in mladostnikih, starih 1–18 let, z de novo ALL
Study in patients switching from agalsidase beta to Replagal (agalsidase alfa)
Študija pri bolnikih, ki so prešli z agalzidaze beta na zdravilo Replagal (agalzidaza alfa)
Study in patients switching from imiglucerase treatment to VPRIV
Študije pri bolnikih, ki so prešli z zdravljenja z imiglucerazo na zdravilo VPRIV
Study in subjects re-treated with CHAMPIX
Študija pri preiskovancih, ki so bili ponovno zdravljeni z zdravilom CHAMPIX
Study in subjects with a history of major depressive disorder
Študija pri preiskovancih s hudo depresivno motnjo v anamnezi
Study in subjects with stable schizophrenia or schizoaffective disorder
Študija pri preiskovancih s stabilno shizofrenijo ali shizoafektivno motnjo
study in women with no uterus
Študija pri ženskah brez maternice
Study initiated in October 2009; Final report foreseen in April 2010
Študija začeta oktobra 2009, končno poročilo predvideno aprila 2010.
Study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were  18 years old.
Raziskava IV je v prvi vrsti ocenila varnost pri 636 bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, starih  18 let.
Study JO25567 was a randomized, open-label, multi-center Phase II study conducted in Japan to evaluate the efficacy and safety of Avastin used in addition to erlotinib in patients with non-squamous NSCLC with EGFR activating mutations (exon 19 deletion or exon 21 L858R mutation) who had not received prior systemic therapy for Stage IIIB/IV or recurrent disease.
Študija JO25567 je bila randomizirana, odprta, multicentrična študija faze II, izvedena na Japonskem, v kateri so ocenjevali učinkovitost in varnost zdravila Avastin, uporabljenega kot dodatek erlotinibu pri bolnikih z neskvamoznim nedrobnoceličnim rakom pljuč z EGFR-aktivirajočimi mutacijami (delecijo eksona 19 ali mutacijo L858R eksona 21), ki niso prejeli predhodnega sistemskega zdravljenja za stadij IIIB/IV ali pri katerih se je bolezen ponovila.
Study LAL-CL08: an open-label, Phase 2 study in infants with rapidly progressive LAL Deficiency to explore long-term safety and efficacy data.
Študija LAL-CL08: odprta študija faze II pri dojenčkih s hitro napredujočim pomanjkanjem LAL za raziskovanje podatkov o dolgoročni varnosti in učinkovitosti.
Study LYM-3002 was a Phase III, randomised, open-label study comparing the efficacy and safety of the combination of bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP; n=243) to that of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; n=244) in adult patients with previously untreated MCL (Stage II, III or IV).
V randomizirani, odprti študiji faze III, LYM-3002, so pri odraslih bolnikih s predhodno nezdravljenim MCL (stopnje II, III ali IV) primerjali učinkovitost in varnost bortezomiba v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom in prednizonom (BzmbR-CAP; n=243) z zdravljenjem z rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom in prednizonom (R-CHOP; n=244).
Study LYM-3002 was a Phase III, randomised, open-label study comparing the efficacy and safety of the combination of bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (BzR-CAP; n=243) to that of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; n=244) in adult patients with previously untreated MCL (Stage II, III or IV).
V randomizirani, odprti študiji faze III, LYM-3002, so pri odraslih bolnikih s predhodno nezdravljenim MCL (stopnje II, III ali IV) primerjali učinkovitost in varnost bortezomiba v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom in prednizonom (BzR-CAP; n=243) z zdravljenjem z rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom in prednizonom (R-CHOP; n=244).
Study LYM-3002 was a Phase III, randomised, open-label study comparing the efficacy and safety of the combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP; n=243) to that of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; n=244) in adult patients with previously untreated MCL (Stage II, III or IV).
V randomizirani, odprti študiji faze III, LYM-3002, so pri odraslih bolnikih s predhodno nezdravljenim MCL (stopnje II, III ali IV) primerjali učinkovitost in varnost zdravila VELCADE v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom in prednizonom (VcR-CAP; n = 243) z zdravljenjem z rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom in prednizonom (R-CHOP; n = 244).
Study MB102129
Študija MB102129
Study MEK116513 was a 2-arm, randomised, open-label, Phase III study comparing dabrafenib and trametinib combination therapy with vemurafenib monotherapy in BRAF V600 mutation-positive metastatic melanoma.
Študija MEK116513 je bila randomizirana, odprta študija faze III z dvema skupinama, v kateri so primerjali uporabo kombinacije dabrafeniba in trametiniba z uporabo vemurafeniba v monoterapiji pri zdravljenju metastatskega melanoma z mutacijo BRAF V600.
Study MenACWY-TT-039(1)
Študija MenACWY-TT-039(1)
Study MenACWY-TT-039(1)*
Študija MenACWY-TT-039(1)
Study MenACWY-TT-040(2)
Študija MenACWY-TT-040(2)
Study MenACWY-TT-104(1)
Študija MenACWY-TT-104(1)
Study MN303 was an optional 6-month blinded continuation of MN301 without theplacebo arm, result ing in a 12-month comparison of leflunomide and sulphasalazine.
Študija MN303 je bila fakultativno 6-mesečno slepo nadaljevanje MN301 brez skupine s placebom in je omogočila 12-mesečno primerjavo leflunomida in sulfasalazina.
Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule
Študija MO16982: uvajalni odmerek 6 mg/kg na teden 3 tedne; sledil je odmerek 6 mg/kg po 3- tedenskem režimu.
Study MV17150
Študija MV17150
Study N01252(1)
Študija N01252(1)
Study N01253(1)
Študija N01253(1)
Study No.
Št. študije
Study NR15961
Študija NR15961
Study number/ Treatment regimensb
Številka študije/ režimi zdravljenjab
Study of sitagliptin in combination with metformin and a PPAR agonist
Študija sitagliptina v kombinaciji z metforminom in agonistom PPAR
Study of sitagliptin in combination with metformin and a sulphonylurea
Študija sitagliptina v kombinaciji z metforminom in s sulfonilsečnino
Study of sitagliptin in combination with metformin and insulin
Študija sitagliptina v kombinaciji z metforminom in insulinom
Study participants
Þátttakendur í rannsókninni
Study performed with
Študija izvedena z
Study Population
Študijska populacija
Study protocols
Protokole študije
Study protocols to be submitted by September
Protokole študije je treba predložiti do septembra 2012.
Study Q-Pan H1N1-001 abridged report for post dose 1 and post dose 2 ( 18 yrs, Dose finding, adjuvanted vaccine vs plain)
2. odmerku ( 18 let, določitev odmerka, adjuvantno cepivo v primerjavi z navadnim)
Study Q-Pan H1N1-003 (6 months-8 yrs, Dose finding,)
študija Q-Pan H1N1-003 (6 mesecev do 8 let, določitev odmerka)
Study RA-I Methotrexate combination (24 and 52 weeks)
Študija RA-I Kombinacija z metotreksatom (24. in 52. teden)
Study Report:
poročilo o
Study results Study GOG-0179
Rezultati preskušanja GOG-0179
Study S3 (131) was an open-label randomised 52 week trial in subjects who received romiplostim or medical standard of care (SOC) treatment.
Študija S3 (131) je bila odprto randomizirano 52-tedensko preskušanje pri bolnikih, ki so prejemali zdravljenje z romiplostimom ali s standardno zdravstveno oskrbo.
Study SC-I: Pre-filled pen (ClickJect) sub-study
Študija SC-I: Podštudija uporabe napolnjenega injekcijskega peresnika (ClickJect)
Study subjects n (%)
Osebe v študiji n (%)
Study TMC114HIV3015 evaluated etravirine 200 mg b.i.d. in combination with other antiretroviral medicinal products in 15 pregnant women during the second and third trimesters of pregnancy and postpartum.
V študiji MC114HIV3015 so pri 15 nosečnicah med drugim in tretjim trimesečjem nosečnosti in v obdobjo po porodu ocenjevali uporabo 200 etravirina b.i.d. v kombinaciji z drugimi protiretrovirusnimi zdravili.
Study to evaluate immediate and longer term antibody titres elicited by one or two doses of Nimenrix administered in children aged 12-23 months.
en ali dva odmerka cepiva Nimenrix, uporabljena pri otrocih, starih od 12
study to further investigate the risk of pneumonia with Relvar Ellipta compared with other ICS/LABA FDC in the treatment of COPD, according to a protocol agreed by the Committee.
Predložiti končno poročilo klinične študije za intervencijsko študijo varnosti po pridobitvi dovoljenja za promet za dodatno preučitev tveganja za pljučnico z zdravilom Relvar Ellipta v primerjavi z drugimi ICS/LABA FDC pri zdravljenju KOPB po protokolu, dogovorjenem s CHMP.
Study treatment continued until disease progression (evidence of radiographic progression, a skeletal- related event, or clinical progression) and the initiation of either a cytotoxic chemotherapy or an investigational agent, or until unacceptable toxicity.
Zdravljenje v okviru študije se je nadaljevalo do napredovanja bolezni (radiografsko potrjeno napredovanje, pojav z okostjem povezanega dogodka ali klinično napredovanje) in uvedbe citotoksične kemoterapije ali preučevanega zdravila, ali do nesprejemljivih toksičnih učinkov.
Study treatments were discontinued at the time of unequivocal clinical progression.
S študijskim zdravljenjem so prekinili, ko je bilo nedvomno ugotovljeno klinično poslabšanje.
Study UV I Treatment  Placebo  Adalimumab
Študija UV I Zdravljenje  Placebo  Adalimumab
Study UV II Treatment  Placebo  Adalimumab
Študija UV II Zdravljenje  Placebo  Adalimumab
Study V72P16 2, 3, 4 months
Študija V72P16 pri 2, 3, 4 mesecih
Study V87P1
Študija V87P1
Study V87P1 Adults Booster (6 months after 2nd dose
Študija V87P1 odrasli obnovitveni odmerek (6 mesecev po 2. odmerku)
Study V87P1 Adults booster after 2nd dose
Štúdia V87P1 Dospelí preočkovanie po
Study V87P1 Elderly Booster (6 months after 2nd dos e)
Študija V87P1 starejši obnovitveni odmerek (6 mesecev po 2. odmerku)
Study V87P1 Elderly booster after 2nd dose
Štúdia V87P1 Staršie osoby preočkovanie po
Study V87P13
Študija V87P13
Study VII
Študija VIII