FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment could continue beyond disease progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator.
Slovenian: Zdravljenje se je lahko nadaljevalo tudi še po napredovanju bolezni, če je bil bolnik klinično stabilen in je raziskovalec presodil, da zdravljenje bolniku klinično koristi.
English: leukocytes); decrease in the number of platelets (bruising or bleeding more easily) - reaction related to the infusion of the medicine - inflammation of the pituitary gland situated at the base of the brain; inflammation of the thyroid; decreased secretion of hormones produced by the adrenal glands - decreased potassium, sodium or calcium in the blood - trouble sleeping - dizziness; lack of energy; inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs - dry eye - abnormal heart rhythm - inflammation of the lungs - inflammation of the intestines; dry mouth - red raised rash, sometimes with blisters; acne-like skin problem; inflammation of the skin; dry,
Slovenian: levkocitov), zmanjšano število trombocitov (večja nagnjenost k podplutbam ali krvavitvam) - reakcije, povezane z infundiranjem zdravila - vnetje žleze hipofize, ki se nahaja na dnu možganov, vnetje ščitnice, zmanjšano izločanje hormonov, ki jih proizvajata nadledvični žlezi - znižanje kalija, natrija ali kalcija v krvi - težave s spanjem - omotica, pomanjkanje energije, vnetje živcev, kar povzroči odrevenelost, šibkost, mravljinčenje ali pekočo bolečino v rokah in nogah - suho oko - nenormalen srčni ritem - vnetje pljuč - vnetje črevesja, suha usta - rdeč, dvignjen izpuščaj, včasih z mehurji, aknam podobne kožne težave, vnetje kože, suha,
English: (n=99), or cetuximab 400 mg/m2 loading dose and then 250 mg/m2 once weekly (n=71).
Slovenian: metotreksat v odmerku 40 mg/m 2 enkrat na teden (n = 64), docetaksel v odmerku 75 mg/m 2 enkrat na vsake 3 tedne (n = 99) ali cetuksimab v polnilnem odmerku 400 mg/m2 in nato v odmerku 250 mg/m enkrat na teden (n = 71).
English: Colitis led to discontinuation of pembrolizumab in 29 (0.5%) patients.
Slovenian: Kolitis je bil razlog za ukinitev zdravljenja s pembrolizumabom pri 29 bolnikih (0,5 %).
English: Among the 1,019 patients, the baseline characteristics were: median age of 54 years (25% age 65 or older); 62% male; and ECOG PS of 0 (94%) and 1 (6%).
Slovenian: Pri 1.019 bolnikih so bile izhodiščne lastnosti naslednje: mediana starost 54 let (25 % bolnikov starih 65 let ali starejših), 62 % bolnikov moškega spola, 94 % bolnikov je imelo oceno zmogljivosti 0 po ECOG lestvici, 6 % bolnikov pa je imelo oceno zmogljivosti 1 po ECOG lestvici.
English: Post-authorisation efficacy study (PAES): The MAH should provide the study report for study P361: A Phase III Randomised, Controlled Clinical Trial of Pembrolizumab with or without Platinum-Based Combination Chemotherapy versus Chemotherapy in Subjects with Advanced or Metastatic Urothelial Carcinoma - Study Report
Slovenian: Študija učinkovitosti po pridobitvi dovoljenja za promet (PAES): Imetnik dovoljenja za promet z zdravilom mora predložiti poročilo študije P361: Randomizirano, kontrolirano klinično preskušanje III. faze pembrolizumaba s kombinirano kemoterapijo na podlagi platine ali brez takšne kemoterapije v primerjavi s kemoterapijo pri bolnikih z napredovalim ali metastatskim urotelijskim rakom - poročilo študije
English: Adrenal insufficiency resolved in 16 patients, 4 with sequelae.
Slovenian: Izzvenela je pri 16 bolnikih, pri 4 je pustila posledice.
English: §% (95% CI) Complete response Partial response p-Value Response duration Median in months (range)
Slovenian: §% (95 % IZ) popolni odgovor delni odgovor vrednost p trajanje odgovora mediana v mesecih (razpon)
English: Figure 1: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-006 (intent to treat population)
Slovenian: Slika 1: Kaplan-Meierjeva krivulja celokupnega preživetja glede na zdravljeno skupino v študiji KEYNOTE-006 (populacija z-namenom-zdravljenja (ITT - intent to treat population))
English: * Assessed by BICR using RECIST 1.1
Slovenian: * Na podlagi ocene BICR z uporabo RECIST 1.1
English: Hypophysitis has also been reported in patients receiving pembrolizumab.
Slovenian: Okužba je morala biti pozdravljena, preden so bolniki prejeli pembrolizumab.
English: Pembrolizumab 2 mg/kg every 3 weeks Pembrolizumab 10 mg/kg every 3 weeks Chemotherapy
Slovenian: opazovani dogodek pembrolizumab 2 mg/kg na 3 tedne kemoterapija pembrolizumab 2 mg/kg na 3 tedne kemoterapija
English: The median duration was 1.6 months (range 1 day to 27.3+ months).
Slovenian: Mediano trajanje hudih kožnih reakcij je bilo 1,6 meseca (v razponu od 1 dneva do 27,3+ meseca).
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: celokupno preživetje (OS)
English: Skin and subcutaneous tissue disorders Very common rash q, pruritus rash q, alopecia, pruritus palmar-plantar erythrodysaesthesia syndrome, rash q,
Slovenian: Bolezni kože in podkožja Zelo pogosti izpuščaj q, pruritus izpuščaj q, alopecija,
English: Vogt-Koyanagi-Harada syndrome Cardiac disorders Common cardiac arrhythmia (including atrial fibrillation)
Slovenian: Srčne bolezni Pogosti motnja srčnega ritma (vključno z atrijsko fibrilacijo)
English: The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, sucrose and polysorbate 80.
Slovenian: Druge sestavine zdravila so L-histidin, L-histidinijev klorid monohidrat, saharoza in polisorbat 80.
English: Treatment modification
Slovenian: POSTOPEK UPORABE
English: Number at Risk Pembrolizumab + Chemo:
Slovenian: število izpostavljenih tveganju pembrolizumab + kemoterapija: kontrola:
English: Table 23: Efficacy results for pembrolizumab plus chemotherapy in KEYNOTE-048 with PDL1 expression (CPS ≥ 1)
Slovenian: Preglednica 23: Rezultati učinkovitosti pembrolizumaba skupaj s kemoterapijo v študiji KEYNOTE-048 z izraženostjo PD-L1 (CPS ≥ 1)
English: Rare small intestinal perforation Hepatobiliary disorders Common hepatitis
Slovenian: Redki perforacija tankega črevesa Bolezni jeter, žolčnika in žolčevodov Pogosti hepatitis
English: The trial excluded patients with autoimmune disease; a medical condition that required immunosuppression; or who had received more than 30 Gy of thoracic radiation within the prior 26 weeks.
Slovenian: V preskušanje niso bili vključeni bolniki z avtoimunsko boleznijo, bolniki z zdravstvenim stanjem, ki je zahtevalo imunosupresijo, in bolniki, ki so bili v zadnjih 26 tednih zdravljeni z več kot 30 Gy obsevanja v predelu prsnega koša.
English: ‡ % (95% CI) Complete response % Partial response % p-Value Response duration Median in months (range)
Slovenian: ‡ % (95 % IZ) popolni odgovor % delni odgovor % vrednost p trajanje odgovora mediana v mesecih (razpon)
English: encephalitis
Slovenian: i, encefalitis
English: OS Number (%) of patients with event Hazard ratio † (95% CI)
Slovenian: celokupno preživetje (OS) število (%) bolnikov z dogodkom razmerje ogroženosti † (95 % IZ)
English: Number (%) of patients with event Hazard ratio* (95% CI) p-Value Median in months (95% CI)
Slovenian: celokupno preživetje (OS) število (%) bolnikov z dogodkom razmerje ogroženosti (HR)* (95 % IZ) vrednost p mediana v mesecih (95 % IZ)
English: Pembrolizumab + Pemetrexed + Platinum Chemotherapy n=410
Slovenian: opazovani dogodek pembrolizumab + pemetreksed + kemoterapija na osnovi platine n = 410
English: • Cetuximab 400 mg/m 2 load then 250 mg/m 2 once weekly, carboplatin AUC 5 mg/mL/min every 3 weeks or cisplatin 100 mg/m 2 every 3 weeks, and 5-FU 1,000 mg/m 2/d 4 days continuous every 3 weeks (maximum of 6 cycles of platinum and 5-FU)
Slovenian: • cetuksimab s polnilnim odmerkom 400 mg/m 2 in nato 250 mg/m 2 enkrat na teden, karboplatin z AUC 5 mg/ml/min na 3 tedne ali cisplatin 100 mg/m 2 na 3 tedne ter
English: Pembrolizumab 10 mg/kg every 3 weeks:
Slovenian: pembrolizumab 10 mg/kg na 3 tedne:
English: Treatment arm PFS rate at 12 months PFS rate at 18 months HR (95% CI) p-value Pembrolizumab + Axitinib 60%
Slovenian: ugodna srednja zdravljena skupina delež PFS po 12 mesecih delež PFS po 18 mesecih HR (95 % IZ) vrednost p pembrolizumab + aksitinib 60 % sunitinib čas v mesecih preživetje brez napredovanja bolezni (PFS) (%) .
English: Number of patients OS
Slovenian: Starejši bolniki
English: % with duration ≥ 6-months Time to Response Median in months (range) PFS*
Slovenian: % s trajanjem ≥ 6 mesecev čas do odgovora mediana v mesecih (razpon) preživetje brez napredovanja bolezni (PFS)* mediana v mesecih (95 % IZ) 6-mesečni delež PFS
English: The primary efficacy outcomes were OS and PFS as assessed by BICR using RECIST v1.1.
Slovenian: Primarni merili izida učinkovitosti sta bili OS in PFS, ocenjeni s slepim neodvisnim centralnim pregledom (BICR) na podlagi meril RECIST v1.1.
English: No clinically important differences in the clearance of pembrolizumab were found between patients with mild hepatic impairment and normal hepatic function.
Slovenian: Med bolniki z blago okvaro jeter in bolniki z normalnim delovanjem jeter ni bilo klinično pomembnih razlik v očistku pembrolizumaba.
English: * Hazard ratio (pembrolizumab compared to chemotherapy) based on the stratified Cox proportional hazard model Based on stratified Log rank test
Slovenian: * Razmerje ogroženosti (HR - hazard ratio) (pembrolizumab v primerjavi z ipilimumabom) na podlagi stratificiranega Coxovega modela sorazmernih ogroženosti Na podlagi stratificiranega log-rank testa
English: Objective response rate ORR % (95% CI) Complete response % Partial response % Response Duration Median in months (range)
Slovenian: objektivni delež odgovora ORR % (95 % IZ) popolni odgovor % delni odgovor % trajanje odgovora mediana v mesecih (razpon)
English: Excipients: L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80.
Slovenian: Pomožne snovi: L-histidin, L-histidinijev klorid monohidrat, saharoza, polisorbat 80.
English: One vial of powder contains 50 mg of pembrolizumab.
Slovenian: Ena viala s praškom vsebuje 50 mg pembrolizumaba.
English: A HR=2.09 [95% CI 0.84,5.23] in OS and HR=1.73 [95% CI 0.77,3.90] in PFS for pembrolizumab combination vs chemotherapy was reported within this study subgroup.
Slovenian: Pri tej študijski podskupini so pri kombiniranem zdravljenju s pembrolizumabom v primerjavi s kemoterapijo poročali o HR = 2,09 [95 % IZ 0,84; 5,23] za celokupno preživetje (OS) in o HR = 1,73 [95 % IZ 0,77; 3,90] za preživetje brez napredovanja bolezni (PFS).
English: Table 26: Efficacy results for pembrolizumab plus chemotherapy and pembrolizumab as monotherapy by PD-L1 Expression in KEYNOTE 048 (CPS ≥ 1 to < 20)
Slovenian: Preglednica 26: Rezultati učinkovitosti pembrolizumaba skupaj s kemoterapijo in samostojnega zdravljenja s pembrolizumabom glede na izraženost PD-L1 v študiji KEYNOTE-048 (CPS ≥ 1 do < 20)
English: Patients were randomised (1:1) to one of the following treatment arms:
Slovenian: Bolnike so randomizirali (v razmerju 1:1:1) v eno od naslednjih terapevtskih skupin:
English: Pembrolizumab 10mg/kg every 2 or 3 weeks (pooled)
Slovenian: pembrolizumab 10 mg/kg na 2 ali 3 tedne (kumulativno)
English: Figure 5: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-024 (intent to treat population)
Slovenian: Slika 5: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni glede na zdravljeno skupino v študiji KEYNOTE-024 (populacija z-namenom-zdravljenja (ITT))
English: Very common (may affect more than 1 in 10 people) - thyroid gland problems - feeling less hungry - headache; change in your sense of taste - high blood pressure - shortness of breath; cough; hoarseness - diarrhoea; stomach pain; nausea; vomiting; constipation - blisters or rash on palms of hands or soles of feet; skin rash; itching - feeling tired; unusual tiredness or weakness; fever - increased liver enzyme levels in the blood; abnormal kidney function test - pain in the muscles and bones; joint or muscle pain, aches or tenderness; pain in arms or legs
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) - težave s ščitnico - manjši občutek lakote - glavobol, spremenjeno okušanje - visok krvni tlak - kratka sapa, kašelj, hripavost - driska, bolečine v trebuhu, občutek siljenja na bruhanje (navzea), bruhanje, zaprtost - mehurji ali izpuščaj na dlaneh ali podplatih, izpuščaj na koži, srbenje - občutek utrujenosti, neobičajna utrujenost ali šibkost, zvišana telesna temperatura - zvišana raven jetrnih encimov v krvi, nenormalni izvidi preiskav delovanja ledvic - bolečina v mišicah in kosteh, bolečine, bolečnost ali občutljivost v sklepih ali mišicah, bolečine v rokah ali nogah
English: Administration of pembrolizumab was permitted beyond RECIST-defined disease progression by BICR or beyond discontinuation of pemetrexed if the patient was clinically stable and deriving clinical benefit as determined by the investigator.
Slovenian: Uporaba pembrolizumaba je bila dovoljena tudi po napredovanju bolezni, kar je bilo ocenjeno s slepim neodvisnim centralnim pregledom (BICR) na podlagi meril RECIST, ali po ukinitvi pemetrekseda, če je bil bolnik po presoji raziskovalca klinično stabilen in je zdravljenje bolniku klinično koristilo.
English: Nephritis occurred in 22 (0.4%) patients, including Grade 2, 3 or 4 cases in 5 (0.1%), 14 (0.2%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab as monotherapy.
Slovenian: Nefritis se je pojavil pri 22 bolnikih (0,4 %), ki so prejemali pembrolizumab kot samostojno zdravilo; pri 5 bolnikih (0,1 %) je bil 2. stopnje, pri 14 bolnikih (0,2 %) 3. stopnje in pri 1 bolniku (< 0,1 %) 4. stopnje.
English: An analysis was performed in KEYNOTE-189 in patients who had PD-L1 TPS < 1% [pembrolizumab combination: n=127 (31%) vs. chemotherapy: n=63 (31%)], TPS 1-49% [pembrolizumab combination: n=128 (31%) vs. chemotherapy: n=58 (28%)] or ≥ 50% [pembrolizumab combination: n=132 (32%) vs. chemotherapy: n=70 (34%)] (see Table 14).
Slovenian: TPS 1-49 % [kombinirano zdravljenje s pembrolizumabom: n = 128 (31 %) v primerjavi s kemoterapijo: n = 58 (28 %)] ali ≥ 50 % [kombinirano zdravljenje s pembrolizumabom: n = 132 (32 %) v primerjavi s kemoterapijo: n = 70 (34 %)] (glejte preglednico 14).
English: Animal reproduction studies have not been conducted with pembrolizumab.
Slovenian: S pembrolizumabom niso izvedli študij vpliva na sposobnost razmnoževanja na živalih.
English: Fatigue has been reported following administration of pembrolizumab (see section 4.8).
Slovenian: Po uporabi pembrolizumaba so poročali o utrujenosti (glejte poglavje 4.8).
English: Immune-related severe skin reactions have been reported in patients receiving pembrolizumab (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali pembrolizumab, so poročali o imunsko pogojenih hudih kožnih reakcijah (glejte poglavje 4.8).
English: Pembrolizumab 2 mg/kg every 3 weeks:
Slovenian: pembrolizumab 2 mg/kg na 3 tedne:
English: Complete response Partial response p-Value
Slovenian: vrednost p objektivni delež odgovora ORR %
English: Very common (may affect more than 1 in 10 people) - decrease in the number of red blood cells - decreased number of white blood cells; decrease in the number of platelets (bruising or bleeding more easily) - decreased potassium in the blood; feeling less hungry - dizziness; headache; inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs; change in your sense of taste - shortness of breath; cough - diarrhoea; nausea; vomiting; constipation; stomach pain - skin rash; itching; hair loss - pain in the muscles and bones; joint pain - unusual tiredness or weakness; swelling; fever - abnormal kidney function test
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) - zmanjšanje števila rdečih krvnih celic - zmanjšano število belih krvnih celic, zmanjšano število trombocitov (večja nagnjenost k podplutbam ali krvavitvam) - znižanje kalija v krvi, manjši občutek lakote - omotica, glavobol, vnetje živcev, kar povzroči odrevenelost, šibkost, mravljinčenje ali pekočo bolečino v rokah in nogah, spremenjeno okušanje - kratka sapa, kašelj - driska, občutek siljenja na bruhanje (navzea), bruhanje, zaprtost, bolečine v trebuhu - kožni izpuščaj, srbenje, izpadanje las/dlak - bolečina v mišicah in kosteh, boleči sklepi - neobičajna utrujenost ali šibkost, otekanje, zvišana telesna temperatura - nenormalni izvidi preiskav delovanja ledvic
English: feeling tired, or chest pain - inflammation of the eyes; eye pain, irritation, itchiness or redness; uncomfortable sensitivity to light; seeing spots - inflammation of the pancreas - hair colour changes; thickened, sometimes scaly, skin growth; small skin bumps, lumps or sores; patches of skin that have lost colour - increased level of amylase, an enzyme that breaks down starch
Slovenian: videnje pik - vnetje trebušne slinavke - spremembe barve las/dlak, zadebeljena, včasih luskasta kožna rašča, majhne kožne bulice, bule ali razjede na koži, razbarvane lise na koži - zvišanje vrednosti amilaze (encima, ki razgrajuje škrob)
English: Pembrolizumab 200 mg every 3 weeks n=154
Slovenian: opazovani dogodek pembrolizumab 200 mg na 3 tedne n = 154
English: The following side effects have been reported in clinical trials with pembrolizumab in combination with chemotherapy:
Slovenian: V kliničnih preskušanjih zdravljenja s pembrolizumabom v kombinaciji s kemoterapijo so poročali o naslednjih neželenih učinkih:
English: No clinically important differences in the clearance of pembrolizumab were found between patients with mild or moderate renal impairment and patients with normal renal function.
Slovenian: Med bolniki z blago ali zmerno okvaro ledvic in bolniki z normalnim delovanjem ledvic ni bilo klinično pomembnih razlik v očistku pembrolizumaba.
English: There is limited data on subjects with stage IIIA according to AJCC 8
Slovenian: O bolnikih z melanomom v stadiju IIIA po 8. izdaji kriterijev AJCC je v času te analize RFS na voljo malo podatkov.
English: Corticosteroids should be administered for Grade ≥ 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper); pembrolizumab should be withheld for Grade 2 pneumonitis, and permanently discontinued for Grade 3, Grade 4 or recurrent Grade 2 pneumonitis (see section 4.2).
Slovenian: Za učinke, ki so ≥ 2. stopnje, je treba uporabiti kortikosteroide (začetni odmerek 1-2 mg/kg/dan prednizona ali ekvivalenta, nato se jih postopno zmanjšuje); uporabo pembrolizumaba je treba v primeru pnevmonitisa 2. stopnje zadržati in jo v primeru pnevmonitisa 3., 4. stopnje ali ponovnega pnevmonitisa 2. stopnje trajno ukiniti (glejte poglavje 4.2).
English: Number (%) of patients with event Median in months (95% CI) Hazard ratio† (95% CI) OS rate at 6 months (95% CI) OS rate at 12 months (95% CI) OS rate at 24 months (95% CI) PFS
Slovenian: število (%) bolnikov z dogodkom mediana v mesecih (95 % IZ) razmerje ogroženosti (HR)† (95 % IZ) vrednost p‡ delež celokupnega preživetja po 6 mesecih (95 % IZ) delež celokupnega preživetja po 12 mesecih (95 % IZ) delež celokupnega preživetja po 24 mesecih (95 % IZ) preživetje brez napredovanja bolezni (PFS) število (%) bolnikov z dogodkom mediana v mesecih (95 % IZ) razmerje ogroženosti (HR) (95 % IZ) vrednost p delež preživetja brez napredovanja bolezni po 6 mesecih (95 % IZ) delež preživetja brez napredovanja bolezni po 12 mesecih (95 % IZ) delež preživetja brez napredovanja bolezni po 24 mesecih (95 % IZ) objektivni delež odgovora
English: Corticosteroids should be administered for Grade ≥ 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper) and, based on severity of creatinine elevations, pembrolizumab should be withheld for Grade 2, and permanently discontinued for Grade 3 or Grade 4 nephritis (see section 4.2).
Slovenian: Za učinke, ki so ≥ 2. stopnje, je treba uporabiti kortikosteroide (začetni odmerek 1-2 mg/kg/dan prednizona ali ekvivalenta, nato se jih postopno zmanjšuje), uporabo pembrolizumaba je treba glede na izrazitost dviga kreatinina zadržati v primeru nefritisa 2. stopnje in jo v primeru nefritisa 3. ali 4. stopnje trajno ukiniti (glejte poglavje 4.2).
English: Figure 3: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-002 (intent to treat population)
Slovenian: Slika 3: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni glede na zdravljeno skupino v študiji KEYNOTE-002 (populacija z-namenom-zdravljenja (ITT))
English: Thyroid disorders, including hypothyroidism, hyperthyroidism and thyroiditis, have been reported in patients receiving pembrolizumab and can occur at any time during treatment.
Slovenian: Pri bolnikih, ki so prejemali pembrolizumab, so poročali o motnjah delovanja ščitnice, ki vključujejo hipotiroidizem, hipertiroidizem in tiroiditis.
English: Renal and urinary disorders Common nephritis z, acute kidney injury acute kidney injury, nephritis
Slovenian: Bolezni sečil Pogosti nefritis z, akutna okvara ledvic akutna okvara ledvic, nefritis
English: Common (may affect up to 1 in 10 people) - lung infection - decrease in the number of platelets (bruising or bleeding more easily); decrease in the number of white blood cell (lymphocytes) - reactions related to the infusion of the medicine - overactive thyroid gland activity; hot flush - decreased sodium, potassium, or calcium in the blood - trouble sleeping - dizziness; inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs; lack of energy; change in your sense of taste - dry eye - abnormal heart rhythm - high blood pressure - inflammation of the lungs - inflammation of the intestines; dry mouth - red raised rash sometimes with blisters; patches of skin which have lost colour; dry, itchy skin;
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - okužba pljuč - zmanjšano število trombocitov (večja nagnjenost k podplutbam ali krvavitvam), zmanjšano število belih krvnih celic (limfocitov) - reakcije, povezane z infundiranjem zdravila - prekomerno delovanje ščitnice, vročinski oblivi - znižanje natrija, kalija ali kalcija v krvi - težave s spanjem - omotica, vnetje živcev, kar povzroči odrevenelost, šibkost, mravljinčenje ali pekočo bolečino v rokah in nogah, pomanjkanje energije, spremenjeno okušanje - suho oko - nenormalen srčni ritem - visok krvni tlak - vnetje pljuč - vnetje črevesja, suha usta - rdeč, dvignjen izpuščaj, včasih z mehurji, kožne lise, ki so izgubile barvo, suha, srbeča koža,
English: Administration of pembrolizumab and axitinib was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered to be deriving clinical benefit by the investigator.
Slovenian: Uporaba pembrolizumaba in aksitiniba je bila dovoljena tudi po napredovanju bolezni, kot to opredeljujejo smernice RECIST, če je bil bolnik klinično stabilen in mu je zdravljenje po presoji raziskovalca klinično koristilo.
English: Treatment arm OS rate at 12 months OS rate at 24 months HR (95% CI) p-value Pembrolizumab
Slovenian: zdravljena skupina delež OS po 12 mesecih delež OS po 24 mesecih HR (95 % IZ) vrednost p pembrolizumab kemoterapija število izpostavljenih tveganju pembrolizumab: kemoterapija:
English: ‡ (95% CI) 29.3 (21.2, 38.5)
Slovenian: (95 % IZ) trajanje odgovora število odzivnih mediana v mesecih (razpon) 7,1 (2,1+; 39,0+) 4,2 (1,2+; 31,5+)
English: Pembrolizumab 2 mg/kg every 3 weeks n=180
Slovenian: opazovani dogodek pembrolizumab 2 mg/kg na 3 tedne n = 180
English: Figure 4: Kaplan-Meier curve for recurrence-free survival by treatment arm in KEYNOTE-054 (intent to treat population)
Slovenian: Slika 4: Kaplan-Meierjeva krivulja preživetja brez ponovitve bolezni (RFS) glede na zdravljeno skupino v študiji KEYNOTE-054 (populacija z-namenom-zdravljenja (ITT))
English: th edition and a subgroup analysis of RFS per AJCC 8
Slovenian: V preskušanje KEYNOTE-054 so bili vključeni bolniki po 7. izdaji kriterijev AJCC, analiza RFS po podskupinah pa je bila po dobljenih rezultatih RFS izvedena po 8. izdaji kriterijev AJCC.
English: 2mg/kg every 3 weeks (n=136)
Slovenian: opazovani dogodek pembrolizumab 2 mg/kg na 3 tedne (n = 136)