natgillin/translations-raw huggingface dataset:
The MAH should submit the final OS data for study CA209238: A Phase 3, randomised double-blind study of OPDIVO versus Yervoy in patients who have undergone complete resection of Stage IIIb/c or Stage IV melanoma.
Randomizovaná dvojito zaslepená štúdia, 3. fázy s OPDIVOM oproti Yervoyu s pacientmi, ktorí podstúpili úplnú resekciu melanómu v štádiu IIIb/c alebo v štádiu IV.
Median time to onset was 3.6 months (range: 0.2-19.6).
Medián času do nástupu bol 3,6 mesiaca (rozsah: 0,2 - 19,6).
Eye disorders Common uveitis, blurred vision blurred vision
Poruchy oka Časté uveitída, rozmazané videnie rozmazané videnie
──Δ─── Nivolumab (events: 50/210), median and 95% CI: N.A. - - -- - - Dacarbazine (events: 96/208), median and 95% CI: 10.84 (9.33, 12.09)
- - -- - - Dakarbazín (udalosti: 96/208), medián a 95 % CI: 10,84 (9,33; 12,09)
In patients treated with nivolumab monotherapy, the incidence of pneumonitis, including interstitial lung disease and lung infiltration, was 3.4% (87/2578).
U pacientov liečených nivolumabom v monoterapii bola incidencia pneumonitídy vrátane intersticiálneho ochorenia pľúc a infiltrácie pľúc 3,4
Hazard ratio 95% CI Rate (95% CI) at 24 months
Pomer rizika 95 % CI Výskyt (95 % CI) pri 24 mesiacoch
Median time to onset was 2.6 months (range: 0.5-21.8).
Medián času do nástupu bol 2,6 mesiaca (rozsah: 0,5 - 21,8).
Nivolumab 1 mg/kg in Combination with Ipilimumab 3 mg/kg
Nivolumab v dávke 1 mg/kg v kombinácii s ipilimumabom v dávke 3 mg/kg
Median duration of responseb
Medián trvania odpovedeg
Progression-free survival Rate (95% CI) at 24 months
Prežívanie bez progresie Výskyt (95 % CI) pri 24 mesiacoch
Grade 3 diarrhoea or colitis observed with nivolumab in combination with ipilimumab requires permanent discontinuation of treatment and initiation of corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Hnačka alebo kolitída 3. stupňa pozorované pri nivolumabe v kombinácii s ipilimumabom si vyžaduje trvalé ukončenie liečby a začatie liečby kortikosteroidmi v dávke zodpovedajúcej metylprednizolónu 1 až 2 mg/kg/deň.
Uncommon tubulointerstitial nephritis, renal failure (including acute kidney injury)a,c General disorders and administration site conditions Very common fatigue
Menej časté tubulointersticiálna nefritída, zlyhanie obličiek (vrátane akútneho poškodenia obličiek)a,c
nivolumab + ipilimumab Median OS (95% CI)
nivolumab + ipilimumab Medián OS (95
In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of rash was 65.0% (291/448).
U pacientov liečených nivolumabom v dávke 1 mg/kg v kombinácii s ipilimumabom v dávke 3 mg/kg pri melanóme bola incidencia vyrážky 65,0 % (291/448).
PFS rate at 12 months and 95% CI: 49% (44, 55) ──Δ─── Nivolumab (events: 183/316), median and 95% CI: 6.87 (4.34, 9.46).
Miera PFS po 12 mesiacoch a 95 % CI: 49 % (44; 55) ──Δ─── Nivolumab (udalosti: 183/316), medián a 95
Median time to onset of these endocrinopathies was 1.9 months (range: 0.0-22.3).
Medián času do nástupu týchto endokrinopatií bol 1,9 mesiaca (rozsah: 0,0-22,3).
The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma was evaluated in a phase 2, multicentre, openlabel, single-arm study (CA209275).
Bezpečnosť a účinnosť nivolumabu v dávke 3 mg/kg ako jedinej látky na liečbu pacientov s lokálne pokročilým alebo metastatickým uroteliálnym karcinómom sa hodnotili v multicentrickej, otvorenej štúdii 2. fázy s jednou skupinou (CA209275).
PD-L1 < 1%, PD-L1+ TAIC abundantd
%, PD-L1+ TAIC výdatnád
Median time to onset was 2.3 months (range: 0.0-18.2).
Medián času do nástupu bol 2,3 mesiaca (rozsah: 0,0 - 18,2).
Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.
Ak máte alogénnu transplantáciu kmeňových buniek, lekár vás bude sledovať z dôvodu prejavov komplikácií.
16.16) and the estimated OS rates were 69.2% (CI: 57.7, 78.2) at 6 months and 45.6% (CI: 34.2, 56.3) at 12 months.
Medián OS bol 9,7 mesiaca (95 % CI:7,26; 16,16) a odhadované pomery OS boli 69,2 % (CI: 57,7; 78,2) po 6 mesiacoch a 45,6 % (CI: 34,2; 56,3) po 12 mesiacoch.
Median time to response Months (range)
Medián času do odpovede Mesiace (rozsah)
Complete response (CR) Partial response (PR) Stable disease (SD)
Kompletná odpoveď (CR)
Grade 2 and Grade 3 cases were reported in 5.1% (131/2578) and 1.2% (31/2578) of patients respectively.
% (131/2 578) a 3. stupňa u 1,2 % (31/2 578) pacientov.
One vial of 24 mL contains 240 mg of nivolumab.
Jedna 24 ml injekčná liekovka obsahuje 240 mg nivolumabu.
In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of thyroid disorders was 25.2% (113/448).
U pacientov liečených nivolumabom v dávke 1 mg/kg v kombinácii s ipilimumabom v dávke 3 mg/kg pri melanóme bola incidencia ochorení štítnej žľazy 25,2 % (113/448).
The overall safety profile of nivolumab 3 mg/kg for the adjuvant treatment of melanoma (n = 452) was consistent with that established across tumour types for nivolumab monotherapy.
V súbore údajov o nivolumabe v dávke 3 mg/kg ako monoterapia na adjuvantnú liečbu melanómu (n = 452) boli najčastejšie nežiaduce reakcie (≥
In patients treated with nivolumab monotherapy, the incidence of diarrhoea, colitis, or frequent bowel movements was 13.1% (339/2578).
U pacientov liečených nivolumabom v monoterapii bola incidencia hnačky, kolitídy alebo častých pohybov čriev 13,1
Single-arm phase 2 study (CA209172)
Štúdia 2.fázy s jednou skupinou (CA209172)
Non-Small Cell Lung Cancer
Nemalobunkový karcinóm pľúc
Inflammation of the joints (arthritis), muscle spasm, muscle weakness Kidney failure (including abrupt loss of kidney function) Oedema (swelling), pain, chest pain, chills
Zápal kĺbov (artritída), svalové kŕče, slabosť svalov Zlyhanie obličiek (vrátane náhlej straty funkcie obličiek)
Table 18: Efficacy results (CA209025)
Výsledky účinnosti (CA209025)
Rash is a composite term which includes maculopapular rash, rash erythematous, rash pruritic, rash follicular, rash macular, rash morbilliform, rash papular, rash pustular, rash papulosquamous, rash vesicular, rash generalised, exfoliative rash, dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis atopic, dermatitis bullous, dermatitis exfoliative, dermatitis psoriasiform, drug eruption and pemphigoid.
e Vyrážka je kompozitný názov, ktorý zahŕňa makulopapulárnu vyrážku, erytematóznu vyrážku, svrbivú vyrážku, folikulárnu vyrážku, makulárnu vyrážku, morbiliformnú vyrážku, papulárnu vyrážku, pustulárnu vyrážku, papuloskvamóznu vyrážku, vezikulárnu vyrážku, generalizovanú vyrážku, dermatitídu, akneiformnú dermatitídu, alergickú dermatitídu, atopickú dermatitídu, bulóznu dermatitídu, exfoliatívnu dermatitídu, psoriaziformnú dermatitídu, liekovú vyrážku a pemfigoid.
Mouth ulcers and cold sores (stomatitis), inflammation of the pancreas (pancreatitis), constipation, dry mouth
Vredy v ústach a opary (stomatitída), zápal podžalúdkovej žľazy (pankreatitída), zápcha, sucho v ústach
Median time to onset was 2.6 months (range: 0.7-12.6).
Medián času do nástupu bol 2,6 mesiaca (rozsah: 0,7 - 12,6).
Nivolumab+ipilimumab (events: 139/314), median and 95% CI: N.A. (38.18, N.A.) OS rate and 95% CI at 12 months: 73% (68, 78), 24 months: 64% (59, 69), and 36 months: 58% (52, 63) ──Δ─── Nivolumab (events: 158/316), median and 95% CI: 37.59 months (29.08, N.A.) OS rate and 95% CI at 12 months: 74% (69, 79), 24 months: 59% (53, 64), and 36 months: 52% (46, 57) Ipilimumab (events: 206/315), median and 95% CI: 19.94 months (16.85, 24.61) OS rate and 95% CI at 12 months: 67% (61, 72), 24 months: 45% (39, 50), and 36 months: 34% (29, 39)
Miera OS a 95 % CI pri 12 mesiacoch: 73 % (68; 78), 24 mesiacoch: 64 % (59; 69) a 36 mesiacoch: 58 % (52; 63) ──Δ─── Nivolumab (udalosti: 158/316), medián a 95 % CI: 37,59 mesiacov (29,08; N.A.)
The PFS HRs for nivolumab vs. chemotherapy were 0.76 (95% CI: 0.54, 1.07) in patients with tumour PD-L1 expression ≥1% and 1.92 (95% CI: 1.05, 3.5) in patients with tumour PD-L1 expression <1%.
PFS HR po nivolumabe oproti chemoterapii bolo 0,76 (95 % CI: 0,54; 1,07) u pacientov s expresiou PD-L1 v nádore ≥ 1
Post authorisation efficacy study (PAES): The MAH should submit the addendum to the CA209205 Final CSR reporting the OS data and data from the discontinuation schedule in Cohort C.
Držiteľ rozhodnutia o registrácii má podať dodatok k finálnemu CSR hláseniu ohľadom údajov OS a údajov o schéme ukončovania liečby v Kohorte
Grade 2 and Grade 3 cases were reported in 20.3% (91/448) and 7.6% (34/448) of patients, respectively.
% (91/448) a 3. stupňa u 7,6 % (34/448) pacientov.
CA209205 Cohort Ba
CA209205 Kohorta Ba
Median (95% CI) months Rate (95% CI) at 12 months
Medián (95 % CI) mesiace Výskyt (95 % CI) po 12 mesiacoch
In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of thyroid disorders was 27.2% (149/547).
U pacientov liečených nivolumabom v dávke 3 mg/kg v kombinácii s ipilimumabom v dávke 1 mg/kg pri RCC bola incidencia ochorení štítnej žľazy 27,2 % (149/547).
Rate (95% CI) At 6 months At 12 months
Výskyt (95 % CI) po 6 mesiacoch po 12 mesiacoch
No Grade 3-5 cases were reported.
Nehlásili sa žiadne prípady 3.5. stupňa.
Efficacy by BRAF status: After18 months of follow-up, BRAF[V600] mutation-positive and BRAF wild-type patients randomised to nivolumab in combination with ipilimumab had a median PFS of 15.5 months (95% CI: 8.0, NA) and 11.3 months (95% CI: 8.3, 22.2), while those in the nivolumab monotherapy arm had a median PFS of 5.6 months (95% CI: 2.8, 9.3) and 7.1 months (95% CI: 4.9, 14.3), respectively.
Účinnosť pomocou stavu BRAF: Po 18 mesiacoch následného sledovania mali pacienti s pozitívnou mutáciou BRAF[V600] a divokým typom BRAF randomizovaní na nivolumab v kombinácii s ipilimumabom medián PFS 15,5 mesiaca (95 % CI: 8,0; NA) a 11,3 mesiaca (95
Unopened vial
Otvorená štúdia
b 25/100 (25%) of the patients in CA209205 Cohort C presented B-Symptoms at baseline.
%) pacientov v štúdii CA209205 Kohorta C malo na začiatku prítomné B-symptómy.
The median age was 61 years (range: 21-85) with 38% ≥ 65 years of age and 8% ≥ 75 years of age.
Medián veku bol 61 rokov (rozsah: 21-85) s vekom ≥ 65 rokov u 38 % a s vekom ≥ 75 rokov u 8
from the study.
V záverečnej analýze
The median age was 66 years (range: 38 to 90) with 55% ≥65 years of age and 14% ≥75 years of age.
Medián veku bol 66 rokov (rozsah: 38 až 90), 55 % s vekom ≥ 65 rokov a 14
Table 2:
Obrázok 2:
Nivolumab+ipilimumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.42 (0.32, 0.56); p-value: < 0.0001 Nivolumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.55 (0.42, 0.73); p-value: < 0.0001
Nivolumab oproti ipilimumabu (primárna analýza) - HR (99,5 % CI): 0,55 (0,42; 0,73); p-hodnota: <
The median age was 62 years (range: 21 to 85) with 34% ≥65 years of age and 7% ≥75 years of age.
Medián veku bol 62 rokov (rozsah: 21 až 85) s vekom ≥ 65 rokov u 34 % a s vekom ≥ 75 rokov u 7
Baseline ECOG performance status score was 0 (24%) or
Východiskové skóre výkonnostného stavu (ECOG) bolo 0 (24
56 (56%) M 44 (44%) F
M 44 (44
The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of metastatic or recurrent SCCHN were evaluated in a phase 3, randomised, open-label study (CA209141).
Bezpečnosť a účinnosť nivolumabu 3 mg/kg ako jedinej látky na liečbu metastatického alebo recidivujúceho SCCHN sa hodnotili v randomizovanej, otvorenej štúdii 3. fázy (CA209141).
Endocrinopathies Skin
Endokrinopatie
The majority of cases were Grade 1 or 2 in severity reported in 8.5% (220/2578) and 3.0% (78/2578) of patients respectively.
% (220/2 578) alebo 2. stupňa u 3,0 % (78/2 578) pacientov.
Table 5: Adverse reactions with nivolumab monotherapy Nivolumab monotherapy
Tabuľka 5: Nežiaduce reakcie pri monoterapii nivolumabom Nivolumab monoterapia
Randomised phase 3 study vs. chemotherapy (CA209037)
3. fázy oproti chemoterapii (CA209037)
Median time to onset was 1.2 months (range: 0.0-24.7).
Medián času do nástupu bol 1,2 mesiaca (rozsah: 0,0-24,7).
The primary OS analysis was not adjusted to account for subsequent therapies, with 54 (40.6%) patients in the chemotherapy arm subsequently receiving an anti-PD1 treatment.
OS nebola upravená tak, aby zahŕňala následné terapie, 54 (40,6
Baseline ECOG performance status score was 0 (90%) or 1 (10%).
Východiskové skóre výkonnostného stavu podľa ECOG bolo 0 (90
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Zoznam pomocných látok dihydrát citrátu sodného chlorid sodný manitol (E421) kyselina pentetová (kyselina dietylentriaminpentaoctová) polysorbát 80 hydroxid sodný (na úpravu pH) kyselina chlorovodíková (na úpravu pH) voda na injekciu
At the time of this analysis, the hazard ratio was 0.66; (99.8% CI 0.48-0.91) with 166/425 events in the combination arm and 209/422 events in the sunitinib arm. At 18 months, the OS rate was 74.3 (95% CI 69.8-78.2) for nivolumab in combination with ipilimumab and 59.9 (95% CI 54.9-64.5) for sunitinib.
Po 18 mesiacoch bola miera OS 74,3 (95 % CI 69,8-78,2) pre nivolumab v kombinácii s ipilimumabom a 59,9 (95 % CI 54,9-64,5) pre sunitinib.
Investigator assessed ORR was 61% (95% CI: 48.9, 72.4) in the combination arm (n = 72) versus 11% (95% CI: 3.0, 25.4) for the ipilimumab arm (n = 37).
Skúšajúcim hodnotené ORR bolo 61 % (95 % CI: 48,9; 72,4) v skupine s kombináciou (n =
Manufacturer Bristol-Myers Squibb S.r.l.
Bristol-Myers Squibb S.r.l.
Progression-free survival Events
Prežívanie bez progresie Udalosti
Common pyrexia, oedema (including peripheral oedema) Uncommon pain, chest pain Investigationsb
Časté pyrexia, edém (vrátane periférneho edému)
Nivolumab 3 mg/kg in Combination with Ipilimumab 1 mg/kg
Nivolumab v dávke 3 mg/kg in v kombinácii s ipilimumabom v dávke 1 mg/kg
Randomisation was stratified by tumour PD-L1 status and M stage (M0/M1a/M1b versus M1c).
(M0/M1a/M1b oproti
Adverse reactions reported in the pooled dataset for patients treated with nivolumab monotherapy (n = 2578) are presented in Table 5.
Nežiaduce reakcie hlásené v zhromaždenom súbore údajov u pacientov liečených nivolumabom monoterapiou (n =
PD-L1 expression ≥ 1%
expresia PD-L1 ≥
If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 1 to 2 mg/kg/day methylprednisolone equivalents, and nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued.
Ak aj napriek začatiu liečby kortikosteroidmi dôjde k zhoršeniu alebo sa stav nezlepší, má sa dávka kortikosteroidu zvýšiť na dávku zodpovedajúcu metylprednizolónu až 1 až 2 mg/kg/deň a liečba nivolumabom alebo nivolumabom v kombinácii s ipilimumabom sa musí natrvalo ukončiť.
Grade 4), and diabetic ketoacidosis (1 Grade 4) were reported.
(3 2. stupňa a 1 3. stupňa) a diabetická ketoacidóza (2 3. stupňa).
Median time to onset was 2.1 months (range: 0.0-16.1).
Medián času do nástupu bol 2,1 mesiaca (rozsah: 0,0-16,1).
CA209205 Cohort B and CA209039
CA209205 Kohorta B a CA209039 (n =
Hazard ratio
Pomer rizika
Recurrence-Free Survival (Months)
Prežívanie bez rekurencie ochorenia (mesiace)
nivolumab Median OS (95% CI)
nivolumab Medián OS (95
Hazard Ratio (95% CI)
Pomer šancí (95 % CI)
dacarbazine (n = 208)
dakarbazín (n =
Median time to onset was 1.8 months (range: 0.0-26.6).
Medián času do nástupu bol 1, 8mesiaca (rozsah: 0,0 - 26,6).
The primary efficacy outcome measure was OS. Key secondary efficacy outcome measures were investigator-assessed PFS and ORR.
Merané kľúčové sekundárne koncové ukazovatele účinnosti hodnotené skúšajúcim boli PFS a ORR.
The estimated 2 and 3 year OS rates were 68% (95% CI: 56, 78) and 61% (95% CI: 49, 71), respectively, for the combination (n = 73) and 53% (95% CI: 36, 68) and 44% (95% CI: 28, 60), respectively, for ipilimumab (n = 37).
73) 68 % (95 % CI: 56; 78) a 61 % (95 % CI: 49; 71), v uvedenom poradí a pre ipilimumab (n =
The OS HRs for nivolumab vs. chemotherapy were 0.69 (95% CI: 0.49, 0.96) in patients with tumour PD-L1 expression ≥1% and 1.52 (95% CI: 0.89, 2.57) in patients with tumour PD-L1 expression <1%.
OS HR po nivolumabe oproti chemoterapii bolo 0,69 (95 % CI: 0,49; 0,96) u pacientov s expresiou PD-L1 v nádore ≥ 1
The median OS was 17.3 months (95% CI: 12.5, 37.8), and the estimated OS rates were 42% (95% CI: 32, 51) at 3 years, 35% (95% CI: 26, 44) at 4 years, and 34% (95% CI: 25, 43) at 5 years (minimum follow-up of 45 months).
OS boli 42 % (95 % CI: 32; 51) pri 3 rokoch, 35 % (95 % CI: 26, 44) pri 4 rokoch a 34
Patients with a baseline performance score ≥ 2, active brain metastases or autoimmune disease, symptomatic interstitial lung disease, and patients who had been receiving systemic immunosuppressants prior to study entry were excluded from the pivotal clinical trials of NSCLC (see sections 4.5 and 5.1).
2, aktívnymi metastázami v mozgu alebo autoimunitným ochorením, symptomatickým intersticiálnym ochorením pľúc a pacienti, ktorí dostali systémové imunosupresíva pred zaradením do štúdie boli z pivotných klinických skúšaní s NSCLC vylúčení (pozri časti 4.5 a 5.1).
Resolution occurred in 191 patients (65.9%) with a median time to resolution of 11.4 weeks (range: 0.1-150.1+).
%) s mediánom času do vyriešenia 11,4 týždňa (rozsah: 0,1 - 150,1+).
The Kaplan-Meier curves for OS are shown in Figure 8.
OS sú uvedené na obrázku 8.
At a minimum follow-up of 9 months, investigator-assessed confirmed ORR was 24.4% (95% CI: 15.3, 35.4).
Pri minimálnom následom sledovaní 9 mesiacov bolo potvrdené ORR vyhodnotené skúšajúcim 24,4
Withhold dose(s) until symptoms resolve and management with corticosteroids, if needed, is complete
Prerušte podávanie dávky (dávok), pokým príznaky neodznejú a ak je to potrebné, nie je ukončená liečba kortikosteroidmi
The majority of patients were white (93%) and male (76%).
Väčšina pacientov boli muži (73
PD-L1 expression < 1%
expresia PD-L1 <
Patients with a baseline performance score ≥ 2, active brain or leptomeningeal metastases, active autoimmune disease, medical conditions requiring systemic immunosuppression, or carcinoma of the nasopharynx or salivary gland as the primary tumour sites were excluded from the SCCHN clinical trial (see sections 4.5 and 5.1).
2, aktívnymi metastázami v mozgu alebo leptomeningeálnymi metastázami, aktívnym autoimunitným ochorením, medicínskymi stavmi vyžadujúcimi si systémovú imunosupresiu, alebo s karcinóm nosohltana alebo slinnej žľazy ako primárnych nádorových miest boli z klinického skúšania s SCCHN vylúčení (pozri časti 4.5 a 5.1).
Hepatic impairment
Pneumonitída Kolitída
Severe infusion reactions have been reported in clinical trials of nivolumab or nivolumab in combination with ipilimumab (see section 4.8).
V klinických skúšaniach s nivolumabom alebo s nivolumabom v kombinácii s ipilimumabom sa hlásili závažné reakcie na infúziu (pozri časť 4.8).
Years from most recent transplant to first dose of study therapy, median (min-max) a 18/80 (22.5%) of the patients in CA209205 Cohort B presented B-Symptoms at baseline.
Roky od poslednej transplantácie do prvej dávky skúšanej liečby, medián (minmax) a 18/80 (22,5
OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
A DOSAHU DETÍ
Withhold dose(s) until symptoms resolve and management with corticosteroids is complete
Prerušte podávanie dávky (dávok), pokým príznaky neodznejú a nie je ukončená liečba kortikosteroidmi
Median time to onset was 2.1 months (range: 0.0-27.6).
Medián času do nástupu bol 2,1 mesiaca (rozsah: 0,0 - 27,6).
Pain in the joints (arthralgia), pain in the muscles and bones (musculoskeletal pain) Feeling tired or weak, fever
Bolesť v kĺboch (artralgia), bolesť vo svaloch a v kostiach (muskuloskeletálna bolesť)
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available post-marketing data).
1/10 000 až < 1/1 000); veľmi zriedkavé (<
Resolution occurred in 33 patients (94.3%) with a median time to resolution of 6.1 weeks (range: 0.3-35.1).
%) s mediánom času do vyriešenia 6,1 týždňa (rozsah: 0,3 - 35,1+).
A group of metabolic complications occurring after cancer treatment characterised by high blood levels of potassium and phosphate, and low blood levels of calcium (tumour lysis syndrome) An inflammatory disorder (most likely of autoimmune origin) affecting the eyes, skin and the membranes of the ears, brain and spinal cord (Vogt-Koyanagi-Harada syndrome) Inflammation of the covering of the heart and accumulation of fluid around the heart (pericardial disorders)
Zápalové ochorenie (najpravdepodobnejšie autoimunitného pôvodu) postihujúce oči, kožu a sliznice uší, mozog a miechu (Vogtov-Koyanagiho-Haradov syndróm)
The trial demonstrated a statistically significant improvement in RFS for patients randomised to the nivolumab arm compared with the ipilimumab 10 mg/kg arm. RFS benefit was consistently demonstrated across subgroups, including tumour PD-L1 expression, BRAF status, and stage of disease.
Skúšanie preukázalo štatisticky významné zlepšenie RFS u pacientov randomizovaných do skupiny s nivolumabom v porovnaní so skupinou s ipilimumabom 10 mg/kg.
In this patient population, objective response was reported in 33 patients (31%) with a median duration of response of 22.9 months (95% CI: 17.0, NR).
%) s mediánom trvania odpovede 22,9 mesiaca (95 % CI: 17,0; NR).
Resolution occurred in 86 patients (85.1%) with a median time to resolution of 6.1 weeks (range: 0.1+-82.9+).
%) s mediánom času do vyriešenia 6,1 týždňa (rozsah: 0,1+-82,9+).
≥ 1% to < 10%a
10 % až <
95% CI: 1.4, 17.9 OS by tumour PD-L1 expression Minimum follow-up: 13.2 months Number of events (number of patients)
95 % CI: 1,4; 17,9 OS pomocou expresie PD-L1 v nádore
Odds ratio (95% CI) p-value
Pomer šancí (95 % CI) p-hodnota
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from available post-marketing data).
1/10 000); neznáme (nemožno odhadnúť z dostupných údajov po uvedení lieku na trh).
Grade 2 and Grade 3 hypopituitarism occurred in 0.4% (2/448) and 0.7% (3/448) of patients, respectively.
% (2/448) a u 0,7 % (3/448) pacientov, v uvedenom poradí.
CA209205 Cohort Ba and CA209039
CA209205 Kohorta Ba a CA209039 (n =
Responses were assessed per RECIST 1.1 for 588/1008 (58.3%) of patients who continued treatment through week 12 and had a follow-up scan at week 12.
Odpovede sa hodnotili pomocou RECIST 1.1 u 588/1 008 (58,3
This leaflet was last revised in
OS sú uvedené na obrázku
Grade 2 cases were reported in 2.2% (10/448) of patients.
% (2/448) pacientov.
Grade 3 and 4 cases were reported in 1.6% (41/2578) and 0.3% (9/2578) of patients, respectively.
Prípady 3. stupňa sa hlásili u 1,6 % (41/2 578) a 4. stupňa u 0,3
docetaxel (n = 290)
292) alebo na docetaxel (n =
A total of 582 patients were randomised to receive either nivolumab 3 mg/kg administered intravenously over 60 minutes every 2 weeks (n = 292) or docetaxel 75 mg/m2 every 3 weeks
Celkovo bolo randomizovaných 582 pacientov, buď na intravenózne podávanie nivolumabu v dávke 3 mg/kg počas 60 minút každé 2 týždne (n =
Patients with a baseline performance score ≥2, active brain metastases or leptomeningeal metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the clinical trials of urothelial carcinoma (see sections 4.5 and 5.1).
2, aktívnymi metastázami v mozgu alebo leptomeningeálnymi metastázami, aktívnym autoimunitným ochorením alebo medicínskymi stavmi vyžadujúcimi si systémovú imunosupresiu, boli z klinických skúšaní s uroteliálnym karcinómom vylúčení (pozri časti 4.5 a 5.1).
Resolution occurred in 192 patients (72.2%) with a median time to resolution of 11.6 weeks (range: 0.1-126.7+).
%) s mediánom času do vyriešenia 11,6 týždňa (rozsah: 0,1-126,7+).
Rare (may affect up to 1 in 1000 people) Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis)
Závažné a pravdepodobne smrteľné olupovanie kože (toxická epidermálna nekrolýza).