natgillin/translations-raw huggingface dataset:
quinolones (antibiotics such as ciprofloxacine to treat infections);
kinoloni (antibiotiki, kot je ciprofloksacin, za zdravljenje okužb);
Quinsair 240 mg BID
Zdravilo Quinsair 240 mg dvakrat na dan
Quinsair 240 mg nebuliser solution
Quinsair 240 mg inhalacijska raztopina za nebulator
Quinsair can cause peripheral neuropathy (nerve damage).
Zdravilo Quinsair lahko povzroči periferno nevropatijo (poškodbo živcev).
Quinsair is a clear, pale yellow nebuliser solution.
Zdravilo Quinsair je bistra, bledorumena inhalacijska raztopina za nebulator.
Quinsair is available as a nebuliser solution in single-dose containers called ‘ampoules’.
Zdravilo Quinsair je na voljo v obliki raztopine za nebulator v enoodmernih vsebnikih, imenovanih
Quinsair may make you feel dizzy, tired or weak, or cause problems with your eyesight.
Zaradi zdravila Quinsair boste morda omotični, utrujeni ali šibki ali pa boste imeli težave z vidom.
Quinsair should be taken by inhalation using a Zirela Nebuliser Handset (including a Zirela Aerosol Head).
Zdravilo Quinsair se uporablja z inhaliranjem s pomočjo nebulatorja Zirela (vključno s pršilno glavo
Quintanrix is available in the following pack sizes: For 2 doses :
Cepivo Quintanrix je na voljo v naslednjih velikostih pakiranja: Za 2 odmerka:
Quintanrix is contra-indicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
Uporaba cepiva Quintanrix je kontraindicirana, če je otrok prebolel encefalopatijo neznanega vzroka, ki se je pojavila v 7 dneh po predhodnem cepljenju s cepivom, ki je vsebovalo tudi komponento proti
Quintanrix is used to vaccinate infants under one year of age against diphtheria, tetanus, pertussis (whooping cough), hepatitis B and ‘invasive’ diseases caused by Hib (such as bacterial meningitis).
Cepivo Quintanrix se uporablja za cepljenje otrok, mlajših od enega leta, proti davici, tetanusu, oslovskemu kašlju, hepatitisu B in „invazivnim“ boleznim, ki jih povzroča Hib (kot je bakterijski meningitis).
Quintanrix powder and suspension for suspension for injection
Quintanrix, prašek in suspenzija za pripravo suspenzije za injiciranje
Quixidar 1.5 mg/0.3 ml injection fondaparinux Na
Quixidar 1,5 mg/0,3 ml injekcija Na fondaparinuks
Quixidar 1.5 mg/0.3 ml solution for injection fondaparinux sodium
Quixidar 1,5 mg/0,3 ml raztopina za injiciranje natrijev fondaparinuks
Quixidar 1.5 mg/0.3 ml solution for injection, pre-filled syringe.
Quixidar 1,5 mg/0,3 ml raztopina za injiciranje, napolnjena injekcijska brizga
Quixidar 10 mg/0.8 ml injection fondaparinux Na
Quixidar 10 mg/0,8 ml injekcija Na fondaparinuks
Quixidar 10 mg/0.8 ml solution for injection Fondaparinux sodium
Quixidar 10 mg/0,8 ml raztopina za injiciranje natrijev fondaparinuks
Quixidar 10 mg/0.8 ml solution for injection, pre-filled syringe.
Quixidar 10 mg/0,8 ml raztopina za injiciranje, napolnjena injekcijska brizga
Quixidar 2.5 mg/0.5 ml injection fondaparinux Na
Quixidar 2,5 mg/0,5 ml injekcija Na fondaparinuks
Quixidar 2.5 mg/0.5 ml solution for injection Fondaparinux sodium
Quixidar 2,5 mg/0,5 ml raztopina za injiciranje natrijev fondaparinuks
Quixidar 2.5 mg/0.5 ml solution for injection, pre-filled syringe.
Quixidar 2,5 mg/0,5 ml raztopina za injiciranje, napolnjena injekcijska brizga
Quixidar 5 mg/0.4 ml injection fondaparinux Na
Quixidar 5 mg/0,4 ml injekcija Na fondaparinuks
Quixidar 5 mg/0.4 ml solution for injection Fondaparinux sodium
Quixidar 5 mg/0,4 ml raztopina za injiciranje natrijev fondaparinuks
Quixidar 5 mg/0.4 ml solution for injection, pre-filled syringe.
Quixidar 5 mg/0,4 ml raztopina za injiciranje, napolnjena injekcijska brizga
Quixidar 7.5 mg/0.6 ml injection fondaparinux Na
Quixidar 7,5 mg/0,6 ml injekcija Na fondaparinuks
Quixidar 7.5 mg/0.6 ml solution for injection Fondaparinux sodium
Quixidar 7,5 mg/0,6 ml raztopina za injiciranje natrijev fondaparinuks
Quixidar 7.5 mg/0.6 ml solution for injection, pre-filled syringe.
Quixidar 7,5 mg/0,6 ml raztopina za injiciranje, napolnjena injekcijska brizga
Quixidar does not have to be kept in the fridge.
Zdravila Quixidar ni treba shranjevati v hladilniku.
Quixidar does not need to be kept in a fridge.
Zdravila Quixidar ni treba shranjevati v hladilniku.
Quixidar does not need to be kept in the fridge.
Zdravila Quixidar ni treba shranjevati v hladilniku.
Quixidar has not been tested in children and adolescents under the age of 17 years.
Pri otrocih in mladostnikih, mlajših od 17 let, uporaba zdravila Quixidar niso raziskovali.
Quixidar has not been tested in children and adolescents under the age of 17 years.
Pri otrocih in mladostnikih, mlajših od 17 let, uporabe zdravila Quixidar niso raziskovali.
Quixidar is a clear and colourless solution for injection.
Quixidar je bistra in brezbarvna raztopina za injiciranje.
Quixidar is a clear and colourless to slightly yellow solution for injection.
Quixidar je bistra in brezbarvna do rahlo rumena raztopina za injiciranje.
Quixidar is an anticoagulant; it prevents the blood from coagulating (clotting).
Zdravilo Quixidar je antikoagulant – preprečuje koagulacijo (strjevanje) krvi.
Quixidar is given by injection under the skin (subcutaneously) into a skin fold of the lower abdominal area.
Zdravilo Quixidar si injicirajte pod kožo (subkutano), v kožno gubo v spodnjem predelu trebuha.
Qutenza cutaneous patch: Store flat in original sachet and carton.
Qutenza dermalni obliž: shranjujte v vodoravnem položaju v originalni vrečki in škatli.
Qutenza has no or negligible influence on the ability to drive and use machines.
Zdravilo Qutenza nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Qutenza is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for pain.
Zdravilo Qutenza je indicirano za zdravljenje periferne nevropatske bolečine pri odraslih osebah samostojno ali v kombinaciji z drugimi zdravili za lajšanje bolečin.
Qutenza is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for pain.
Zdravilo Qutenza uporabljamo za zdravljenje periferne nevropatske bolečine pri odraslih osebah samostojno ali v kombinaciji z drugimi zdravili za lajšanje bolečin.
Qutenza is required to be administered by a physician or under the supervision of a physician.
Zdravilo Qutenza mora aplicirati zdravnik ali zdravstveni delavec pod nadzorom zdravnika.
Qutenza must be applied to intact, non-irritated, dry skin, and allowed to remain in place for 30 minutes for the feet (e.g.
Zdravilo Qutenza je treba aplicirati na čisto, nerazdraženo, suho kožo, kjer mora učinkovati 30 minut na predelu stopal (npr. pri nevropatiji, povezani s HIV, boleči diabetični periferni nevropatiji) oz.
Qutenza should be applied to the most painful skin areas (using up to a maximum of 4 patches).
Zdravilo Qutenza je treba aplicirati na najbolj boleče predele kože (skupno največ 4 obliže).
Qutenza should be used only on dry, intact (unbroken) skin and not on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.
Zdravilo Qutenza je treba aplicirati na suho, nepoškodovano (nerazpokano) kožo, vendar ne na obraz, lasišče in/ali v bližino sluznic.
Qutenza should be used with caution if you are pregnant and/or breastfeeding.
Če ste noseči in/ali dojite, je pri uporabi zdravila Qutenza potrebna previdnost.
Qutenza with food and drink
Zdravilo Qutenza skupaj s hrano in pijačo
r r
0,0457
R(-) methadone AUC 0.99 (0.91-1.09) ↔
AUC R(-) metadona 0,99 (0,91-1,09) ↔
R(-) methadone Cmax 1.03 (0.97-1.09) ↔
Cmax R(-) metadona 1,03 (0,97-1,09) ↔
R(-) methadone Cmin 1.02 (0.93-1.12) ↔
Cmin R(-) metadona 1,02 (0,93-1,12) ↔
R(-) methadone Cmin ↓ 15% R(-) methadone Cmax ↓ 24%
R(-) metadon Cmin ↓ 15% R(-) metadon Cmax ↓ 24
R(-) methadone: AUC: ↓ 16%
R(-) metadon: AUC: ↓ 16
R--FC (N=276)
R-FC n = 276)
R-CHOP, 223
CHOP: 205 R-CHOP: 223
R-CHVP-IFN, 175
R-CHVP- IFN: 175
R-FC (N=408)
R-FC (n = 408)
R-methadone
Izrivanje metadona s
R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin.
S-varfarinu ali R-varfarinu (substrat CYP2C9) niti ni vplival na spremembe protrombinskega časa, ki jih povzroča varfarin.
R/I Cohort (N=10)
O/N kohorta (N = 10)
R/I Cohort (N=203)
O/N kohorta (N = 203)
r/paritapr
(0,93-1,10)
r/paritapr evir/riton
IMUNOSUPRESIVI
r/paritapr evir/riton avir
aritaprevir/ri tonavir
r/paritapre
tonavir
r/paritapre vir
kontraindicirana
r/ritonavir
ritonavirjem.
R076477-SCH-303
R076477-SCH-305
R107504, R084536 and R104065 (formed by O- demethylation) were identified as minor plasma metabolites.
R107504, R084536 in R104065 (ki nastanejo z O-demetilacijo) so bili opredeljeni kot manjši presnovki v plazmi.
R342G
E341K
R342L
R342Q
R342P
R342X
R342Q
R342G
R342X
E341D
R363P
E358K
RA adult patients
Odrasli bolniki z revmatoidnim artritisom
RA Patients
Bolniki z revmatoidnim artritisom
RA patients have an increased risk for cardiovascular disorders and should have risk factors (e.g. hypertension, hyperlipidaemia) managed as part of usual standard of care.
Bolniki z revmatoidnim artritisom imajo večje tveganje za srčno-žilne bolezni, zato mora njihova običajna standardna obravnava vključevati obvladanje dejavnikov tveganja (npr. hipertenzije, hiperlipidemije).
RA patients may be at a higher risk (on average 2-3 fold) for the development of lymphoma.
Bolnike z RA bolj ogroža (v povprečju 2– do 3-krat bolj) pojav limfomov.
RA Patients Pharmacodynamic effects
Bolniki z revmatoidnim artritisom Farmakodinamični učinki
RA Patients Posology
Bolniki z revmatoidnim artritisom Odmerjanje
RA studies 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 IV je bila dodatna primarna končna točka po 52 tednih upočasnitev napredovanja bolezni (ugotovljena z izvidi rentgenskega slikanja).
RA Study Ia**
Študija revmatoidnega artritisa Ia
RA Study IIa**
Študija revmatoidnega artritisa IIa
RA Study IIIa**
Študija revmatoidnega artritisa IIIa
RA study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were  18 years old.
V študiji revmatoidnega artritisa IV je bila v prvi vrsti ocenjena varnost pri 636 bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, starih  18 let.
RA, sJIA and pJIA Patients ≥ 30 kg
Bolniki z revmatoidnim artritisom, sJIA in pJIA ≥ 30 kg
RA: Use of Kineret in children and adolescents with Rheumatoid Arthritis has not been fully investigated and therefore cannot be recommended.
RA: Uporaba zdravila Kineret pri otrocih in mladostnikih z revmatoidnim artritisom ni bila povsem raziskana, zato je ni mogoče priporočiti.
Rabbits
Zajci
Rabbits given fulvestrant failed to maintain pregnancy.
Kunci, ki so prejemali fulvestrant, niso mogli ohraniti brejosti.
Rabbits must not be given overdoses of Econor as this may disturb gastrointestinal flora (gut bacteria) leading to the development of enterotoxaemia (infection of the gut).
Kuncem se ne smejo dajati preveliki odmerki zdravila Econor, saj bi lahko spremenili želodčno- črevesno floro (črevesne bakterije) in povzročili razvoj enterotoksemije (okužbe črevesja).
Rabbits were shown to be especially sensitive to intravenous administration of tacrolimus, reversible cardiotoxic effects being observed.
Ugotovljeno je, da so kunci posebej občutljivi za intravensko uporabljeni takrolimusa; opažali so reverzibilne toksične učinke na srcu.
Rabbits.
Kunci
Rabies
Steklina:
Rabies recombinant canarypox virus (vCP65) ..............................................................  10 6.8 FAID*50
Rekombinantni poxvirus kanarčkov, ki vsebuje antigen virusa stekline (vCP65) ........... 10 6,8 FAID*50
Rabies recombinant canarypox virus (vCP65) ................................................................  106.8 FAID*50
Rekombinantni poxvirus kanarčkov, ki vsebuje antigen virusa stekline (vCP65) .......... 10 6,8 FAID*50
Rabies recombinant canarypox virus (vCP65) .................................................................  106.8 FAID50
Rekombinantni poxvirus kanarčkov, ki vsebuje antigen virusa stekline (vCP65) .........................  10 6,8
RABIES VACCINE DO NOT TOUCH
NE DOTIKAJTE SE - CEPIVO PROTI STEKLINI
RABIES VACCINE DO NOT TOUCH
NE DOTIKAJTE SE – CEPIVO PROTI STEKLINI
Rabies virus, strain SAD Vnukovo-32 ≥ 2.0 IU***/ml
Virus stekline, sev SAD Vnukovo-32 ≥ 2,0 IU***/ml
Rabies:
Steklina
Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.
Rabigen SAG2 peroralna suspenzija za lisice in rakunaste pse.
Rabipur Day 0,3,7
Rabipur, dan 0, 3,
Race (White/Black/Asian) %
Rasa (belci/črnci/azijci)% belci
Race (White/Black/Other)
Rasa (belci/črnci/drugi)
Race and ethnicity
Rasa in etnična pripadnost
Race does not affect apparent clearance of tasimelteon.
Rasa ne vpliva na navidezni očistek tasimelteona.
Race, n (%) White
Rasa, n (%) Belci
Race: a population pharmacokinetic analysis of samples from Phase II clinical trials indicated no effect of race on the pharmacokinetics of atazanavir.
Rasa: proučevanje populacijske farmakokinetike v študijah II. faze ni pokazalo, da bi rasa vplivala na farmakokinetiko atazanavirja.
Race: Black/ African
Rasa: Črnci/afriški
Race: no relevant difference between Caucasian, Asian and Black subjects has been observed.
Rasa: Med belci, azijci in črnci niso opazili pomembne razlike.
Race: White
Rasa: Belci
racing heart, a sensation of a rapid, forceful, or irregular beating of the heart
hitro bitje srca, občutek hitrega, silovitega, ali nepravilnega bitje srca
Racing or irregularity of the heartbeat
hitro ali neredno bitje srca zadihanost
RAD Neurim Pharmaceuticals EEC Limited Tel: +44 7563543352 (UK)
Tel: +44 7563543352 (UK)
RADIANT-4 (study CRAD001T2302), a randomised, double-blind, multicentre, phase III study of Afinitor plus best supportive care (BSC) versus placebo plus BSC was conducted in patients with advanced, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin without a history of and no active symptoms related to carcinoid syndrome.
Študija RADIANT-4 (študija CRAD001T2302) je bila randomizirana, dvojno slepa, multicentrična študija faze III, v kateri so primerjali zdravilo Afinitor s placebom, oba skupaj z najboljšo podporno oskrbo, pri bolnikih z napredovalimi dobro diferenciranimi (gradus 1 ali gradus 2) nefunkcionalnimi nevroendokrinimi tumorji gastrointestinalnega ali pljučnega izvora, ki nimajo in niso nikdar imeli simptomov karcinoidnega sindroma.
Radiated RF
Oddajana RF
radiation for pain relief
lajšanje bolečine
radiation injury
radiacijske poškodbe,
radiation injury, pain, taste perversion
poškodba zaradi obsevanja, bolečina, spremenjeno okušanje
Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy) may occur in patients who are also treated with radiation before, during or after their pemetrexed therapy
radiacijska pljučnica (brazgotinjenje pljučnih mešičkov, povezano z obsevanjem) se lahko pojavi pri bolnikih, ki so zdravljeni tudi z obsevanjem pred, med ali po zdravljenju s pemetreksedom.
Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy) may occur in patients who are also treated with radiation either before, during or after their Pemetrexed Lilly therapy.
Radiacijska pljučnica (brazgotinjenje pljučnih mešičkov, povezano z obsevanjem) se lahko pojavi pri bolnikih, ki so zdravljeni tudi z obsevanjem pred, med ali po zdravljenju z zdravilom Pemetreksed Lilly.
Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy) may occur in patients who are also treated with radiation either before, during or after their Pemetrexed medac therapy.
pancitopenija - skupno nizko število belih krvnih celic, rdečih krvnih celic in trombocitov radiacijska pljučnica (brazgotinjenje pljučnih mešičkov, povezano z obsevanjem) se lahko pojavi pri bolnikih, ki so zdravljeni tudi z obsevanjem pred zdravljenjem z zdravilom Pemetreksed medac, med njim ali po njem .
Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy) may occur in patients who are also treated with radiation either before, during or after their Pemetrexed Sandoz therapy.
Radiacijska pljučnica (brazgotinjenje pljučnih mešičkov, povezano z obsevanjem) se lahko pojavi pri bolnikih, ki so zdravljeni tudi z obsevanjem pred, med ali po zdravljenju z zdravilom Pemetreksed Sandoz.
Radiation protection precautions in accordance with national regulations must be taken.
Previdnostni ukrepi za zaščito pred sevanjem morajo biti v skladu z nacionalnimi predpisi.
Radiation protection precautions in accordance with national regulations must therefore be taken.
Zaradi tega moramo upoštevati nacionalne predpise glede previdnostnih ukrepov za zaščito pred ionizirajočimi sevanji.
Radiation protection precautions in accordance with national regulations must therefore be taken.
Zaradi tega morate upoštevati nacionalne predpise glede previdnostnih ukrepov za zaščito pred ionizirajočimi sevanji.
Radiation recall
kožna reakcija po
Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy, from days to years after the radiation.
Radiacijski izpuščaj (kožni izpuščaj kot pri hudi sončni opeklini), ki se lahko pojavi na koži, ki je bila v preteklosti izpostavljena obsevanju, in sicer od nekaj dni do več let po obsevanju..
Radiation recall phenomena have rarely been reported.
Redko so poročali o pojavu zapoznelih reakcij zaradi izpostavitve obsevanju.
Radiation safety – Product handling
Varnost pri sevanju – ravnanje z zdravilom
Radiation therapy
Zdravljenje z obsevanjem
Radiation therapy reactions
Reakcije po obsevanju
Radiation therapy to bone
zdravljenje kosti z obsevanjem
Radiation treatment
Zdravljenje z obsevanjem
Radiation was delivered with megavoltage equipment using once daily fractionation (2 Gy per day, 5 days per week for 7 weeks, for a total dose of
Bolnike so obsevali z megavoltažno opremo s frakcioniranjem enkrat dnevno (2 Gy na dan, 5 dni na teden 7 tednov, tako da je bil celotni odmerek 70–72 Gy).
Radiation was delivered with megavoltage equipment using once daily fractionation (2 Gy per day, 5 days per week for 7 weeks, for a total dose of
Bolnike so obsevali z megavoltažno opremo s frakcioniranjem enkrat na dan (2 Gy na dan, 5 dni na teden 7 tednov, tako da je bil celotni odmerek 70–72 Gy).
Radiation was delivered with megavoltage equipment using once daily fractionation (2 Gy per day, 5 days per week for 7 weeks, for a total dose of 70-72 Gy).
Bolnike so obsevali z megavoltažno opremo s frakcioniranjem enkrat na dan (2 Gy na dan, 5 dni na teden 7 tednov, tako da je bil celotni odmerek 70–72 Gy).
Radiation was delivered with megavoltage equipment using once daily fractionation (2 Gy per day, 5 days per week for 7 weeks, for a total dose of 70-72 Gy).
Za pospešene sheme so priporočili celotni odmerek 70 Gy, za hiperfrakcionirne sheme pa 74 Gy.
radicular syndrome (neck or back pain and other symptoms such as numbness, tingling and weakness in the arms or legs)
radikularni sindrom (bolečine v vratu in hrbtu in drugi simptomi, kot so otopelost, mravljinčenje ter šibkost rok in nog)
Radiculopathic events1, 4
radikulopatski dogodki1,4
Radio Frequency RF emissions
Radijske frekvence RF sevanja
Radio labelled tolvaptan experiments showed that 40% of the radioactivity was recovered in the urine and 59% was recovered in the faeces where unchanged tolvaptan accounted for 32% of radioactivity.
Poskusi z radiološko označenim tolvaptanom so pokazali, da je bilo 40 % radioaktivnosti najdene v urinu in 59 % v blatu, medtem ko je nespremenjen tolvaptan predstavljal 32 % radioaktivnosti.
Radio labelled tolvaptan experiments showed that 40% of the radioactivity was recovered in the urine and 59% was recovered in the faeces, where unchanged tolvaptan accounted for 32% of radioactivity.
Poskusi z radiološko označenim tolvaptanom so pokazali, da je bilo 40 % radioaktivnosti najdene v urinu in 59 % v blatu, medtem ko je nespremenjen tolvaptan predstavljal 32 % radioaktivnosti.
Radioactive material.
radioaktivni material
Radioactive medicinal products should be received, used and administered only by authorised persons in designated clinical settings.
Radiofarmake sme sprejemati, uporabljati in dajati samo pooblaščeno osebje v izbranih kliničnih ustanovah.
Radioactivity in bottom piece of ITLC-SG MAM strip (Rf 0-0.40) A = 100 x ----------------------------------------------------------------------------------
radioaktivnost spodnjega kosa ITLC-SG MAM traku (Rf 0-0,40) A = 100 x
Radiographic Endpoints (mean change from baseline)
Radiološki cilji (povprečna sprememba od izhodišča)
Radiographic mean (SD) changes from baseline in total vdH-S score at week 52 in the overall population of GO-BEFORE
Radiografska srednja vrednost (SD) sprememb glede na začetne vrednosti skupnega rezultata vdH-S v 52. tednu pri celotni skupini bolnikov, vključenih v študijo GO-BEFORE
Radiographic Mean Changes at Week 52 in RA Study V
Preglednica 5: Povprečne rentgenografske spremembe po 52 tednih študije revmatoidnega artritisa V
Radiographic Mean Changes at Week 52 in RA Study V
Preglednica 7: Povprečne rentgenografske spremembe po 52 tednih študije revmatoidnega artritisa V
Radiographic mean changes over 52 weeks in Study II
Povprečne radiološke spremembe v 52 tednih študije II.
Radiographic Non-Progression n (%) (change from
Ne-napredovanje, merjeno radiološko n (%)
Radiographic progression free survival (rPFS) was assessed with the use of sequential imaging studies as defined by PCWG2 criteria (for bone lesions) and modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria (for soft tissue lesions).
Radiografsko potrjeno preživetje brez napredovanja bolezni (rPFS- Radiographic progression free survival) so ocenili z zaporednimi slikovnimi preiskavami po kriterijih PCWG2 (pri kostnih lezijah) in prilagojenimi kriteriji za vrednotenje odziva pri solidnih tumorjih (RECIST - Response Evaluation Criteria In Solid Tumors) pri lezijah mehkega tkiva.
Radiographic progression was assessed with the use of sequential imaging studies as defined by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria (for bone lesions) and/or Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) criteria (for soft tissue lesions).
Radiografsko napredovanje je bilo ocenjeno s pomočjo študij sekvenčnega slikanja po kriterijih PCWG2 (Prostate Cancer Clinical Trials Working Group 2) (za kostne lezije) in/ali kriterijih RECIST različica 1.1 (Response Evaluation Criteria in Solid Tumors) (za lezije v mehkem tkivu).
Radiographic Progression-free Survival (rPFS)
preživetje brez napredovanja bolezni (rPFS)
Radiographic progression-free survival as assessed by the investigator using RECIST v 1.1 for soft tissue and appearance of 2 or more bone lesions in bone scan was 8.3 months for patients treated with enzalutamide and 2.9 months for patients who received placebo (HR = 0.404, 95% CI: [0.350, 0.466]; p < 0.0001).
Radiografsko preživetje brez napredovanja, ki ga je ocenil raziskovalec na podlagi RECIST v1.1 za mehka tkiva in pojav 2 ali več kostnih lezij na slikanjih kosti, je bilo pri prejemnikih enzalutamida 8,3 meseca in pri prejemnikih placeba 2,9 meseca (razmerje ogroženosti = 0,404, 95 % IZ: [0,350, 0,466], p < 0,0001).
Radioiodine-refractory was defined as one or more measurable lesions either with a lack of iodine uptake or with progression in spite of radioactive-iodine (RAI) therapy, or having a cumulative activity of RAI of >600 mCi or 22 GBq with the last dose at least 6 months prior to study entry.
Odpornost proti radioaktivnemu jodu je bila opredeljena kot ena ali več merljivih lezij bodisi brez privzema joda bodisi z napredovanjem bolezni kljub zdravljenju z radioaktivnim jodom (RAI) ali s kumulativno aktivnostjo RAI >600 mCi ali 22 GBq z zadnjim odmerkom vsaj 6 mesecev pred vključitvijo v študijo.