natgillin/translations-raw huggingface dataset:
In the clinical trials the outcome for anidulafungin with C. parapsilosis was not statistically different from other species however, the use of echinocandins in candidaemia due to C. parapsilosis may not be regarded as therapy of first choice
U kliničkim ispitivanjima ishod za anidulafungin kod C. parapsilosis nije bio statistički različit od drugih vrsta, međutim, primjena ehinokandina u kandidemiji izazvanoj s C. parapsilosis ne mora se smatrati terapijom prvog izbora
In the clinical trials with the vaccine, most side effects were mild in nature and short term.
U kliničkim ispitivanjima s cjepivom, većina nuspojava bila je blage naravi i kratkog trajanja.
In the clinical trials, there was an apparently higher incidence of infections among subjects ≥ 65 years of age, compared to younger subjects, although experience is limited.
Iako je iskustvo ograničeno, u kliničkim je istraživanjima incidencija infekcija u ispitanika u dobi ≥ 65 godina starosti bila naizgled veća nego u mlađih ispitanika.
In the CLL11 study, 27% (90 out of 336) of patients treated with Gazyvaro plus chlorambucil had moderate renal impairment (CrCl < 50 mL/min).
U ispitivanju CLL11, 27% (90 od 336) bolesnika liječenih lijekom Gazyvaro i klorambucilom imalo je umjereno oštećenje funkcije bubrega (CrCl < 50 ml/min).
In the cohort of patients not treated with a concomitant statin, the mean baseline LDL-C was 142.1 mg/dL.
U kohorti bolesnika koji nisu istodobno liječeni statinom, srednja početna vrijednost LDL-C bila je 142,1 mg/dl.
In the cohort of patients on background statin, the mean baseline LDL-C was 112.7 mg/dL.
U kohorti bolesnika koji su kao osnovnu terapiju uzimali statine, srednja početnja vrijednost LDL-C bila je 112,7 mg/dl.
In the combination therapy arm of study MEK115306 pyrexia was reported in 57% (119/209) of patients with 7% Grade 3, as compared to the dabrafenib monotherapy arm with 33% (69/211) of patients reporting pyrexia, 2% Grade 3.
U skupini koja je primala kombiniranu terapiju u ispitivanju MEK115306 pireksija je prijavljena u 57% (119/209) bolesnika od čega je 7% bilo 3. stupnja, a u skupini koja je primala dabrafenib kao monoterapiju pireksija je prijavljena u 33% (69/211) bolesnika od čega je 2% bilo 3. stupnja.
In the combined studies of GEMINI I and II the adverse reactions that occurred in ≥5% were nausea, nasopharyngitis, upper respiratory tract infection, arthralgia, pyrexia, fatigue, headache, cough.
U kombiniranim ispitivanjima GEMINI I i II nuspojave koje su se javljale u >5% bile su mučnina, nazofaringitis, infekcija gornjeg dišnog sustava, artralgija, pireksija, umor, glavobolja, kašalj.
In the comparator arm patients received 1% hydrocortisone acetate ointment (HA) for head and neck and 0.1% hydrocortisone butyrate ointment for trunk and limbs (n=111) twice a day for 2 weeks and subsequently HA twice a day to all affected areas.
U usporednoj skupini bolesnicima se primjenjivala mast s 1% hidrokortizon acetata (HA) za glavu i vrat i mast s 0,1% hidrokortizon butirata za trup i udove (n = 111) dvaput na dan tijekom 2 tjedna te nakon toga HA dvaput na dan na sva zahvaćena područja.
In the completed phase II and phase III registration studies, 4,006 patients were exposed to dulaglutide alone or in combination with other glucose lowering medicinal products.
U završenim registracijskim ispitivanjima faze II i faze III, 4006 bolesnika bilo je izloženo dulaglutidu u monoterapiji ili u kombinaciji s drugim lijekovima za snižavanje razine glukoze.
In the completed uncontrolled study 060103, 16 out of 45 (35.6%) of previously untreated patients with severe haemophilia A (FVIII < 1%) and at least 25 EDs to FVIII developed FVIII inhibitors: 7 (15.6%) subjects developed high-titre inhibitors and 9 (20%) subjects developed low-titre inhibitors, 1 of which was also classified as a transient inhibitor.
U dovršenom nekontroliranom ispitivanju 060103, 16 od 45 (35,6%) prethodno neliječenih bolesnika s teškom hemofilijom A (FVIII < 1%) i najmanje 25 dana izloženosti faktoru VIII razvilo je inhibitore FVIII: 7 (15,6%) ispitanika razvilo je inhibitore u visokom titru, a 9 (20%) ispitanika razvilo je inhibitore u niskom titru, od kojih je 1 također klasificiran kao prolazni inhibitor.
In the complicated community acquired pneumonia study that compared Zinforo with ceftriaxone plus vancomycin, 90% of the patients treated with Zinforo were cured, compared with 100% of those receiving ceftriaxone plus vancomycin.
U ispitivanju komplicirane izvanbolnički stečene pneumonije u kojem je lijek Zinforo uspoređen s kombinacijom lijekova ceftriakson i vankomicin izliječeno je 90 % bolesnika koji su dobivali lijek Zinforo, u usporedbi sa 100 % bolesnika koji su dobivali lijekove ceftriakson i vankomicin.
in the concentration of this
porast koncentracija ovog
In the CONFIRMS study, the proportion of patients achieving the primary efficacy endpoint (sUA <
Udio bolesnika koji su postigli primarni ishod djelotvornosti (razina mokraćne kiseline u serumu
In the consistency study (Q-Pan-H5N1-002), a 4-fold increase in serum neutralising antibody against A/Vietnam/1194/2004 was at day 42 achieved in 65.5% of subjects aged 18-60 years and in 24.1% of subjects over 60 years of age.
U ispitivanju konzistencije (Q-Pan-H5N1-002) 42. dana postignut je četverostruki porast neutralizirajućih protutijela protiv soja A/Vietnam/1194/2004 u serumu 65,5% ispitanika od 18 do 60 godina, odnosno u 24,1% ispitanika starijih od 60 godina.
In the context of signal evaluation activities, the MAH has conducted a search in its safety database of all cases of paraesthesia reported cumulatively until 30 April 2015.
U kontekstu aktivnosti procjene signala, nositelj odobrenja proveo je pretraživanje baze podataka o sigurnosti za sve slučajeve parestezije prijavljene do 30. travnja 2015.
In the controlled and non-controlled periods of psoriasis, psoriatic arthritis and Crohn’s disease clinical studies, representing 10,935 patient-years of exposure in 5,884 patients, the median follow-up was 1.0 years; 3.2 years for psoriasis studies, 1.0 year for psoriatic arthritis studies and 0.6 year for Crohn’s disease studies.
Tijekom kontroliranog i nekontroliranog razdoblja kliničkog ispitivanja psorijaze, psorijatičnog artritisa i Crohnove bolesti, koje predstavlja 10 935 bolesnik-godina izloženosti, u 5884 bolesnika, medijan praćenja bio je 1,0 godina; 3,2 godine za ispitivanja psorijaze, 1,0 godina za ispitivanja psorijatičnog artritisa i 0,6 godina za ispitivanja Crohnove bolesti.
In the controlled and non-controlled periods of psoriasis, psoriatic arthritis and Crohn’s disease clinical studies, representing 10,953 patient-years of exposure in 5,884 patients, the median follow up was 0.99 years; 3.2 years for psoriasis studies, 1.0 year for psoriatic arthritis studies and 0.6 year for Crohn’s disease studies.
U kontroliranim i nekontroliranim razdobljima kliničkih ispitivanja psorijaze, psorijatičnog artritisa i Crohnovom bolesti, koje je predstavilo izloženost od 10 953 bolesnik-godina u 5884 bolesnika, medijan praćenja bio je 0,99 godina; 3,2 godine za ispitivanja psorijaze, 1,0 godina za ispitivanja psorijatičnog artritisa i 0,6 godina za ispitivanja Crohnove bolesti.
In the controlled and uncontrolled clinical studies of Xiapex in Peyronie’s disease corporal rupture and other serious penile injury were reported uncommonly (see section 4.4)
U kontroliranim i nekontroliranim kliničkim ispitivanjima Xiapexa u Peyronijevoj bolesti ruptura korpusa i druge ozbiljne ozljede penisa zabilježene su manje često (vidjeti dio 4.4).
In the controlled and uncontrolled periods of the pivotal UC trials with a mean follow-up of 1 year, the incidence of ALT elevations ≥ 5 x ULN was 0.7% in patients receiving golimumab during the maintenance portion of the UC study.
U kontroliranim i nekontroliranim razdobljima pivotalnih ispitivanja u bolesnika s UC, s medijanom praćenja od približno 2 godine, udio bolesnika s porastom razina ALT-a ≥ 5 x iznad GGN iznosio je 0,8% u bolesnika koji su primali golimumab tijekom razdoblja održavanja u sklopu ispitivanja u bolesnika s UC.
In the controlled and uncontrolled portions of these trials with a median follow-up of approximately 2 years, a greater incidence of lymphoma was observed in patients receiving golimumab 100 mg compared with patients receiving golimumab 50 mg.
U kontroliranim i nekontroliranim dijelovima ispitivanja s medijanom praćenja do 3 godine primijećena je viša incidencija limfoma u bolesnika liječenih golimumabom u dozi od 100 mg u odnosu na bolesnike liječene golimumabom u dozi od 50 mg.
In the controlled clinical studies in chronic ITP with eltrombopag, increases in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin were observed (see section 4.8).
U kontroliranim kliničkim ispitivanjima kronične ITP s eltrombopagom, zamijećen je porast serumske alanin aminotransferaze (ALT), aspartat aminotransferaze (AST) i bilirubina (vidjeti dio 4.8).
In the controlled clinical trial population, the adverse reaction profile in patients with BMI > 40 (86/1436 or 6%) showed no meaningful difference relative to patients with BMI ≤ 40.
U populaciji iz kontroliranih kliničkih ispitivanja, profil nuspojava u bolesnika sa ITM >40 (86/1436 ili 6%) nije pokazao značajne razlike u odnosu na bolesnike sa ITM ≤40.
In the controlled period of RA and PsA pivotal trials, mild ALT elevations (> 1 and < 3 x upper limit of normal (ULN)) occurred in similar proportions of golimumab and control patients in the RA and PsA studies (22.1% to 27.4% of patients); in the AS and nr-Axial SpA studies, more golimumab-treated patients (26.9%) than control patients (10.6%) had mild ALT elevations.
U kontroliranom razdoblju pivotalnih ispitivanja u bolesnika s RA i PsA blago povećanje razine ALT-a (> 1 i < 3 x iznad gornje granice normale (GGN)) nastupilo je u sličnom omjeru u bolesnika koji su primali golimumab i u bolesnika u kontrolnoj skupini (22,1% naprama 27,4% bolesnika); u ispitivanju u bolesnika s ankilozantnim spondilitisom i aksijalnim spondiloartritisom bez radiološkog dokaza blago povećanje razine ALT-a imalo je više bolesnika koji su primali golimumab (26,9%) nego onih u kontrolnoj skupini (10,6%).
In the controlled period of RA and PsA pivotal trials, mild ALT elevations (> 1 and < 3 x upper limit of normal (ULN)) occurred in similar proportions of golimumab and control patients in the RA and PsA studies (22.1% to 27.4% of patients); in the AS and nr-Axial SpA studies, more golimumab-treated patients (26.9%) than control patients (10.6%) had mild ALT elevations.
U kontroliranom razdoblju pivotalnih ispitivanja u bolesnika s RA i PsA blago povećanje razine ALT-a (> 1 i < 3 x iznad gornje granice normale (GGN)) nastupilo je u sličnom omjeru u bolesnika koji su primali golimumab i u bolesnika u kontrolnoj skupini (22,1% naprama 27,4% bolesnika); u ispitivanju u bolesnika s ankilozantnim spondilitisom i aksijalnim spondiloartritisom bez radiološkog dokaza,blago povećanje razine ALT-a imalo je više bolesnika koji su primali golimumab (26,9%) nego onih u kontrolnoj skupini (10,6%).
In the controlled period of the pivotal trials in RA, PsA, AS, nr-Axial SpA, and UC, upper respiratory tract infection was the most common adverse drug reaction (ADR) reported in 12.6% of golimumab-treated patients compared with 11.0% of control patients.
U kontroliranom razdoblju pivotalnih ispitivanja u bolesnika s RA, PsA, AS, aksijalnim spondiloartritisom bez radiološkog dokaza i UC, infekcija gornjih dišnih puteva bila je najčešće prijavljena nuspojava, a pojavila se u 12,6% bolesnika liječenih golimumabom u odnosu na 11,0% bolesnika u kontrolnim skupinama.
In the controlled period of the UC pivotal trials of golimumab induction, mild ALT elevations (> 1 and < 3 x ULN) occurred in similar proportions of golimumab- treated and control patients (8.0% to 6.9%, respectively).
U kontroliranom razdoblju pivotalnih ispitivanja uvodne terapije golimumabom u bolesnika s UC, blago povećanje razine ALT-a (> 1 i < 3 x GGN) nastupilo je u sličnom omjeru u bolesnika koji su primali golimumab i u bolesnika u kontrolnoj skupini (8,0% naprama 6,9% bolesnika).
In the controlled period of the UC pivotal trials of golimumab induction, mild ALT elevations (> 1 and < 3 x ULN) occurred in similar proportions of golimumab-treated and control patients (8.0% to 6.9%, respectively).
U kontroliranom razdoblju pivotalnih ispitivanja uvodne terapije golimumabom u bolesnika s UC, blago povećanje razine ALT-a (> 1 i < 3 x GGN) nastupilo je u sličnom omjeru u bolesnika koji su primali golimumab i u bolesnika u kontrolnoj skupini (8,0% naprama 6,9% bolesnika).
In the controlled periods of pivotal trials and through approximately 2 years of follow-up, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between the golimumab and the control groups.
U kontroliranim razdobljima pivotalnih ispitivanja s približno 4 godine praćenja, incidencija malignih bolesti koje nisu limfomi (osim nemelanomskog raka kože) bila je slična u skupini koja je primala golimumab i u kontrolnim skupinama.
In the controlled periods of the pivotal UC trials, of golimumab induction, ALT elevations ≥ 5 x ULN occurred in similar proportions of golimumab- treated patients compared to placebo-treated patients (0.3% to 1.0%, respectively).
U kontroliranim razdobljima pivotalnih ispitivanja uvodne terapije golimumabom u bolesnika s UC, povećanje razine ALT-a ≥ 5 x iznad GGN nastupilo je u sličnom omjeru u bolesnika koji su primali golimumab i u bolesnika koji su primali placebo (0,3% naprama 1,0% bolesnika).
In the controlled periods of the pivotal UC trials, of golimumab induction, ALT elevations ≥ 5 x ULN occurred in similar proportions of golimumab-treated patients compared to placebo-treated patients (0.3% to 1.0%, respectively).
U kontroliranim razdobljima pivotalnih ispitivanja uvodne terapije golimumabom u bolesnika s UC, povećanje razine ALT-a ≥ 5 x iznad GGN nastupilo je u sličnom omjeru u bolesnika koji su primali golimumab i u bolesnika koji su primali placebo (0,3% naprama 1,0% bolesnika).
In the controlled portions of clinical studies of TNF-blocking agents, more cases of malignancies including lymphoma have been observed among patients receiving a TNF blocker compared with control patients.
U kontroliranim dijelovima kliničkih ispitivanja TNF–blokatora zabilježeno je više slučajeva zloćudnih bolesti, uključujući limfome, u bolesnika koji su primali TNF-blokator u odnosu na kontrolnu skupinu bolesnika.
In the controlled portions of clinical trials of all the TNF-blocking agents including Simponi, more cases of lymphoma have been observed among patients receiving anti-TNF treatment compared with control patients.
U kontroliranim dijelovima kliničkih ispitivanja TNF-blokatora, uključujući Simponi, zabilježeno je više slučajeva limfoma u bolesnika koji su primali anti-TNF terapiju u odnosu na kontrolnu skupinu bolesnika.
In the controlled portions of the Simponi Phase IIb and Phase III clinical trials in RA, PsA, AS, and UC, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between the Simponi and the control groups.
U kontroliranim dijelovima kliničkih ispitivanja lijeka Simponi faze IIb i faze III u bolesnika s RA, PsA, AS i UC, incidencija malignih bolesti koje nisu limfomi (osim nemelanomskog raka kože), bila je slična u skupini koja je primala Simponi i u kontrolnim skupinama.
In the cumulative week 96 pooled resistance analysis for patients receiving rilpivirine in combination with emtricitabine/tenofovir disoproxil fumarate, a greater risk of virologic failure for patients in the rilpivirine arm was observed within the first 48 weeks of these studies (11.5% in the rilpivirine arm and 4.2% in the efavirenz arm) while low rates of virologic failure, similar between the treatment arms, were observed from the week 48 to week 96 analysis (15 patients or 2.7% in the rilpivirine arm and 14 patients or 2.6% in the efavirenz arm).
U analizi objedinjenih podataka o rezistenciji iz 96. tjedna u pacijenata koji su primali rilpivirin u kombinaciji s emtricitabinom/tenofovor dizoproksil fumaratom opažen je veći rizik od virološkog neuspjeha u pacijenata u skupinama koje su primale rilpivirin tijekom prvih 48 tjedana u ovim kliničkim ispitivanjima (11,5% u skupinama koje su primale rilpivirin i 4,2% u skupinama koje su primale efavirenz), dok su niske stope virološkog neuspjeha, koje su bile slične u obje terapijske skupine, bile opažene u analizi podataka iz razdoblja od 48. do 96. tjedna (15 pacijenata ili 2,7% u skupinama koje su primale rilpivirin i 14 pacijenata ili 2,6% u skupinama koje su primale efavirenz).
In the current PSUR, a large number of cases includes immediate local ocular tissue irritation, angioedema, urticarial, eczema and allergic dermatitis.
U ovom PSUR-u navodi se velik broj slučajeva koji uključuju trenutnu lokalnu iritaciju očnog tkiva, angioedem, urtikariju, ekcem i alergijski dermatitis.
In the cytokine-pre-treated subgroup, the majority (75 %) had received interferon based treatment.
U skupini ranije liječenih citokinima, većina (75%) je primala terapiju temeljenu na interferonu.
In the days or weeks after vaccination with vaccines given routinely every year to prevent flu, the side effects listed below have occurred.
U danima ili tjednima nakon cijepljenja cjepivima koja se rutinski daju svake godine radi sprječavanja gripe pojavile su se nuspojave navedene u nastavku.
In the description of the Phase 3 study outcomes for Study C211, HPC3008 and HPC3006, SVR12, considered virologic cure, was defined based on HCV RNA below the limit of quantification (25 IU/ml) using the last measurement in the visit window 12 weeks after the planned end of treatment.
Prema opisu ishoda faze III ispitivanja za Ispitivanje C211, HPC3008 i HPC3006, SVR12 koji se smatrao virološkim izlječenjem, definiran je na temelju procjene HCV RNK ispod granice kvantifikacije (25 IU/ml) s time da se koristilo posljednje mjerenje u vremenskom prozoru posjete 12 tjedana nakon planiranog završetka liječenja.
In the descriptive follow-up overall survival analysis, the hazard ratio was 0.75 (95% CI 0.64, 0.88).
U deskriptivnoj naknadnoj analizi ukupnog preživljenja, omjer hazarda iznosio je 0,75 (95% CI: 0,64; 0,88).
In the dog, changes were observed in the liver and gall bladder at exposures approximately 8-fold higher than human exposure observed at the recommended dose (200 mg b.i.d.).
U pasa, promjene su opažene u jetri i žučnom mjehuru pri izloženostima otprilike 8 puta višoj od izloženosti opažene u čovjeka pri preporučenoj dozi (200 mg b.i.d.).
In the Doppler studies, using SonoVue to measure blood flow in large blood vessels improved the quality of the scan when testing the cerebral arteries (in the head), the carotids (in the neck) and the portal vein (leading to the liver), but not the renal arteries (leading to the kidneys).
U ispitivanjima Dopplera, primjena lijeka SonoVue za mjerenje protoka krvi u velikim krvnim žilama poboljšala je kvalitetu skena prilikom testiranja cerebralnih arterija (u glavi), karotida (u vratu) i portalne vene (koja vodi u jetru), no ne renalnih arterija (koje vode u bubrege).
In the double blind placebo controlled studies, 529 patients were treated with rasagiline 1 mg/day for 212 patient years and 539 patients received placebo for 213 patient years.
U dvostruko slijepim placebo kontroliranim ispitivanjima 529 bolesnika bilo je liječeno razagilinom 1 mg/dan kroz 212 bolesničkih godina, a 539 bolesnika je primalo placebo kroz 213 bolesničkih godina.
In the double blind portion of the three phase 3 placebo-controlled clinical studies in Dupuytren’s contracture, 17% of Xiapex-treated patients had mild reactions (i.e. pruritus) after up to 3 injections.
U dvostruko slijepom dijelu tri placebom kontrolirana klinička ispitivanja faze III u bolesnika s Dupuytrenovom kontrakturom, 17% bolesnika liječenih Xiapexom imalo je blage reakcije (tj. svrbež) nakon najviše 3 injekcije.
In the double blind study SP512 Part I, 177 patients received rotigotine and 96 patients received placebo.
U dvostruko slijepom ispitivanju (SP512 I dio) 177 bolesnika primalo je rotigotin, a 96 bolesnika primalo je placebo.
In the double blind study SP512 Part I, 177 patients received rotigotine and 96 patients received placebo.
U dvostruko slijepom ispitivanju SP512 I dio 177 bolesnika primalo je rotigotin, a 96 bolesnika primalo je placebo.
In the double blind study SP512 Part I, 177 patients received rotigotine and 96 patients received placebo.
U dvostruko-slijepom ispitivanju SP512 I dio, 177 bolesnika primalo je rotigotin, a 96 bolesnika primalo je placebo.
In the double-blind controlled studies, 774 patients received tocilizumab 4 mg/kg in combination with MTX, 1870 patients received tocilizumab 8 mg/kg in combination with MTX or other DMARDs and 288 patients received tocilizumab 8 mg/kg monotherapy.
U dvostruko slijepim kontroliranim kliničkim ispitivanjima, 774 bolesnika primala su tocilizumab u dozi od 4 mg/kg u kombinaciji s MTX-om, 1870 bolesnika primala su tocilizumab u dozi od 8 mg/kg u kombinaciji s MTX-om ili drugim antireumatskim lijekovima koji mijenjaju tijek bolesti (DMARD-ovi), dok je 288 bolesnika primalo tocilizumab u dozi od 8 mg/kg kao monoterapiju.
In the Double-blind Placebo-controlled Phase of the 52-week trial, from baseline to last visit there was a mean decrease in prolactin levels in Abilify Maintena (−0.38 ng/ml) compared with a mean increase in placebo (1.67 ng/ml).
U dvostruko slijepoj, placebom kontroliranoj fazi 52-tjednog ispitivanja, razina prolaktina se od početne do posljednje posjete u prosjeku snizila u skupini koja je primala Abilify Maintena (−0,38 ng/ml) za razliku od skupine koja je primala placebo u kojoj se u prosjeku povisila (1,67 ng/ml).
In the double-blind portion of the two phase 3 placebo-controlled clinical trials in Peyronie’s disease, a greater proportion of Xiapex-treated patients (4%) compared to placebo-treated patients (1%) had localized pruritus after up to 4 treatment cycles (involving up to 8 Xiapex injections).
U dvostruko slijepom dijelu dva placebom kontrolirana klinička ispitivanja faze III u bolesnika s Peyronijevom bolesti, veći udio bolesnika liječenih Xiapexom (4%) u usporedbi s bolesnicima liječenima placebom (1%) imao je lokaliziran svrbež nakon najviše 4 ciklusa liječenja (uključujući najviše 8 injekcija Xiapexa).
In the double-blind study SP513 Part I, 213 patients received rotigotine, 227 received ropinirole and 117 patients received placebo.
U dvostruko slijepom ispitivanju SP513 I dio 213 bolesnika primalo je rotigotin, 227 ropinirol i 117 placebo.
In the double-blind study SP513 Part I, 213 patients received rotigotine, 227 received ropinirole and 117 patients received placebo.
U dvostruko slijepom ispitivanju SP513 I dio, 213 bolesnika primalo je rotigotin, 227 ropinirol i 117 placebo.
In the double-blind study SP513 Part I, 213 patients received rotigotine, 227 received ropinirole and 117 patients received placebo.
U dvostruko-slijepom ispitivanju SP513 I dio, 213 bolesnika primalo je je rotigotin, 227 ropinirol i 117 placebo.
In the double-blind study SP515, 201 patients received rotigotine, 200 received pramipexole and 100 patients received placebo.
U dvostruko-slijepom ispitivanju SP515 201 bolesnik primao je rotigotin, 200 je primalo pramipeksol i 100 bolesnika je primalo placebo.
In the DTC study (see Lenvima SmPC), 88% of all patients had a baseline TSH level less than or equal to
U ispitivanju diferenciranog karcinoma štitnjače (vidjeti Sažetak opisa svojstava lijeka za Lenvimu), 88% svih bolesnika imalo je razinu TSH-a na početku ispitivanja manju ili jednaku 0,5 mU/l.
In the DTC study (see Lenvima SmPC), haemorrhage was reported in 34.9% of lenvatinib-treated patients versus 18.3% of placebo-treated patients.
U ispitivanju diferenciranog karcinoma štitnjače (vidjeti Sažetak opisa svojstava lijeka za Lenvimu), krvarenje je zabilježeno u 34,9% bolesnika liječenih lenvatinibom naspram 18,3% bolesnika liječena placebom.