FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 5: Adverse reactions with nivolumab monotherapy Nivolumab monotherapy
Slovak: Tabuľka 5: Nežiaduce reakcie pri monoterapii nivolumabom Nivolumab monoterapia
English: Randomised phase 3 study vs. chemotherapy (CA209037)
Slovak: 3. fázy oproti chemoterapii (CA209037)
English: Median time to onset was 1.2 months (range: 0.0-24.7).
Slovak: Medián času do nástupu bol 1,2 mesiaca (rozsah: 0,0-24,7).
English: 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.
Slovak: OS nebola upravená tak, aby zahŕňala následné terapie, 54 (40,6
English: Baseline ECOG performance status score was 0 (90%) or 1 (10%).
Slovak: Východiskové skóre výkonnostného stavu podľa ECOG bolo 0 (90
English: For Grade 2 or 3 serum creatinine elevation, nivolumab or nivolumab in combination with ipilimumab should be withheld, and corticosteroids should be initiated at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Slovak: Z dôvodu vzostupu kreatinínu v sére 2. alebo 3. stupňa sa má podávanie nivolumabu alebo nivolumabu v kombinácii s ipilimumabom prerušiť a má sa začať liečba kortikosteroidmi v dávke zodpovedajúcej metylprednizolónu 0,5 až 1 mg/kg/deň.
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Slovak: 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
English: 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.
Slovak: 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.
English: 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).
Slovak: Skúšajúcim hodnotené ORR bolo 61 % (95 % CI: 48,9; 72,4) v skupine s kombináciou (n =
English: Manufacturer Bristol-Myers Squibb S.r.l.
Slovak: Bristol-Myers Squibb S.r.l.
English: Progression-free survival Events
Slovak: Prežívanie bez progresie Udalosti
English: Common pyrexia, oedema (including peripheral oedema) Uncommon pain, chest pain Investigationsb
Slovak: Časté pyrexia, edém (vrátane periférneho edému)
English: Nivolumab 3 mg/kg in Combination with Ipilimumab 1 mg/kg
Slovak: Nivolumab v dávke 3 mg/kg in v kombinácii s ipilimumabom v dávke 1 mg/kg
English: If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 2 to 4 mg/kg/day methylprednisolone equivalents and nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued.
Slovak: Ak aj napriek začatiu liečby kortikosteroidmi dôjde k zhoršeniu alebo sa stav nezlepší, dávka kortikosteroidu sa má zvýšiť na dávku zodpovedajúcu metylprednizolónu na 2 až 4 mg/kg/deň a liečba nivolumabom alebo nivolumabom v kombinácii s ipilimumabom sa musí natrvalo ukončiť.
English: Randomisation was stratified by tumour PD-L1 status and M stage (M0/M1a/M1b versus M1c).
Slovak: (M0/M1a/M1b oproti
English: Adverse reactions reported in the pooled dataset for patients treated with nivolumab monotherapy (n = 2578) are presented in Table 5.
Slovak: Nežiaduce reakcie hlásené v zhromaždenom súbore údajov u pacientov liečených nivolumabom monoterapiou (n =
English: PD-L1 expression ≥ 1%
Slovak: expresia PD-L1 ≥
English: 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.
Slovak: 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.
English: Grade 4), and diabetic ketoacidosis (1 Grade 4) were reported.
Slovak: (3 2. stupňa a 1 3. stupňa) a diabetická ketoacidóza (2 3. stupňa).
English: For symptomatic hypothyroidism, nivolumab or nivolumab in combination with ipilimumab should be withheld, and thyroid hormone replacement should be initiated as needed.
Slovak: Z dôvodu symptomatického hypotyreoidizmu sa má liečba nivolumabom alebo nivolumabom v kombinácii s ipilimumabom prerušiť a ak je to potrebné má sa začať substitučné podávanie tyreoidného hormónu.
English: Median time to onset was 2.1 months (range: 0.0-16.1).
Slovak: Medián času do nástupu bol 2,1 mesiaca (rozsah: 0,0-16,1).
English: CA209205 Cohort B and CA209039
Slovak: CA209205 Kohorta B a CA209039 (n =
English: Hazard ratio
Slovak: Pomer rizika
English: Recurrence-Free Survival (Months)
Slovak: Prežívanie bez rekurencie ochorenia (mesiace)
English: nivolumab Median OS (95% CI)
Slovak: nivolumab Medián OS (95
English: Hazard Ratio (95% CI)
Slovak: Pomer šancí (95 % CI)
English: dacarbazine (n = 208)
Slovak: dakarbazín (n =
English: Median time to onset was 1.8 months (range: 0.0-26.6).
Slovak: Medián času do nástupu bol 1, 8mesiaca (rozsah: 0,0 - 26,6).
English: The primary efficacy outcome measure was OS. Key secondary efficacy outcome measures were investigator-assessed PFS and ORR.
Slovak: Merané kľúčové sekundárne koncové ukazovatele účinnosti hodnotené skúšajúcim boli PFS a ORR.
English: 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).
Slovak: 73) 68 % (95 % CI: 56; 78) a 61 % (95 % CI: 49; 71), v uvedenom poradí a pre ipilimumab (n =
English: 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%.
Slovak: OS HR po nivolumabe oproti chemoterapii bolo 0,69 (95 % CI: 0,49; 0,96) u pacientov s expresiou PD-L1 v nádore ≥ 1
English: 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).
Slovak: OS boli 42 % (95 % CI: 32; 51) pri 3 rokoch, 35 % (95 % CI: 26, 44) pri 4 rokoch a 34
English: 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).
Slovak: 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).
English: Resolution occurred in 191 patients (65.9%) with a median time to resolution of 11.4 weeks (range: 0.1-150.1+).
Slovak: %) s mediánom času do vyriešenia 11,4 týždňa (rozsah: 0,1 - 150,1+).
English: The Kaplan-Meier curves for OS are shown in Figure 8.
Slovak: OS sú uvedené na obrázku 8.
English: At a minimum follow-up of 9 months, investigator-assessed confirmed ORR was 24.4% (95% CI: 15.3, 35.4).
Slovak: Pri minimálnom následom sledovaní 9 mesiacov bolo potvrdené ORR vyhodnotené skúšajúcim 24,4
English: Withhold dose(s) until symptoms resolve and management with corticosteroids, if needed, is complete
Slovak: Prerušte podávanie dávky (dávok), pokým príznaky neodznejú a ak je to potrebné, nie je ukončená liečba kortikosteroidmi
English: The majority of patients were white (93%) and male (76%).
Slovak: Väčšina pacientov boli muži (73
English: PD-L1 expression < 1%
Slovak: expresia PD-L1 <
English: 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).
Slovak: 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).
English: Severe pneumonitis or interstitial lung disease, including fatal cases, has been observed with nivolumab monotherapy or nivolumab in combination with ipilimumab (see section 4.8).
Slovak: Pri monoterapii nivolumabom alebo pri nivolumabe v kombinácii s ipilimumabom sa pozorovala závažná pneumonitída alebo intersticiálne ochorenie pľúc vrátane smrteľných prípadov (pozri časť 4.8).
English: Hepatic impairment
Slovak: Pneumonitída Kolitída
English: Severe infusion reactions have been reported in clinical trials of nivolumab or nivolumab in combination with ipilimumab (see section 4.8).
Slovak: V klinických skúšaniach s nivolumabom alebo s nivolumabom v kombinácii s ipilimumabom sa hlásili závažné reakcie na infúziu (pozri časť 4.8).
English: 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.
Slovak: Roky od poslednej transplantácie do prvej dávky skúšanej liečby, medián (minmax) a 18/80 (22,5
English: 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.
Slovak: Ak aj napriek začatiu liečby kortikosteroidmi dôjde k zhoršeniu stavu alebo sa stav nezlepší, dávka kortikosteroidu sa má 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.
English: Severe rash has been observed with nivolumab in combination with ipilimumab and, less commonly, with nivolumab as monotherapy (see section 4.8).
Slovak: Pri liečbe nivolumabom v kombinácii s ipilimumabom a menej často pri nivolumabe monoterapii sa pozorovala závažná vyrážka (pozri časť 4.8).
English: OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Slovak: A DOSAHU DETÍ
English: Withhold dose(s) until symptoms resolve and management with corticosteroids is complete
Slovak: Prerušte podávanie dávky (dávok), pokým príznaky neodznejú a nie je ukončená liečba kortikosteroidmi
English: For symptomatic hyperthyroidism, nivolumab or nivolumab in combination with ipilimumab should be withheld and antithyroid medication should be initiated as needed.
Slovak: Z dôvodu symptomatického hypertyreoidizmu sa má liečba nivolumabom alebo nivolumabom v kombinácii s ipilimumabom prerušiť a ak je to potrebné má sa začať tyreostatická liečba.
English: Severe hepatitis has been observed with nivolumab monotherapy or nivolumab in combination with ipilimumab (see section 4.8).
Slovak: Pri monoterapii nivolumabom alebo pri nivolumabe v kombinácii s ipilimumabom sa pozorovala závažná hepatitída (pozri časť 4.8).
English: Median time to onset was 2.1 months (range: 0.0-27.6).
Slovak: Medián času do nástupu bol 2,1 mesiaca (rozsah: 0,0 - 27,6).
English: Pain in the joints (arthralgia), pain in the muscles and bones (musculoskeletal pain) Feeling tired or weak, fever
Slovak: Bolesť v kĺboch (artralgia), bolesť vo svaloch a v kostiach (muskuloskeletálna bolesť)
English: 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).
Slovak: 1/10 000 až < 1/1 000); veľmi zriedkavé (<
English: Resolution occurred in 33 patients (94.3%) with a median time to resolution of 6.1 weeks (range: 0.3-35.1).
Slovak: %) s mediánom času do vyriešenia 6,1 týždňa (rozsah: 0,3 - 35,1+).
English: 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)
Slovak: Zápalové ochorenie (najpravdepodobnejšie autoimunitného pôvodu) postihujúce oči, kožu a sliznice uší, mozog a miechu (Vogtov-Koyanagiho-Haradov syndróm)
English: 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.
Slovak: Skúšanie preukázalo štatisticky významné zlepšenie RFS u pacientov randomizovaných do skupiny s nivolumabom v porovnaní so skupinou s ipilimumabom 10 mg/kg.
English: 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).
Slovak: %) s mediánom trvania odpovede 22,9 mesiaca (95 % CI: 17,0; NR).
English: Resolution occurred in 86 patients (85.1%) with a median time to resolution of 6.1 weeks (range: 0.1+-82.9+).
Slovak: %) s mediánom času do vyriešenia 6,1 týždňa (rozsah: 0,1+-82,9+).
English: ≥ 1% to < 10%a
Slovak: 10 % až <
English: 95% CI: 1.4, 17.9 OS by tumour PD-L1 expression Minimum follow-up: 13.2 months Number of events (number of patients)
Slovak: 95 % CI: 1,4; 17,9 OS pomocou expresie PD-L1 v nádore
English: Odds ratio (95% CI) p-value
Slovak: Pomer šancí (95 % CI) p-hodnota
English: 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).
Slovak: 1/10 000); neznáme (nemožno odhadnúť z dostupných údajov po uvedení lieku na trh).
English: Grade 2 and Grade 3 hypopituitarism occurred in 0.4% (2/448) and 0.7% (3/448) of patients, respectively.
Slovak: % (2/448) a u 0,7 % (3/448) pacientov, v uvedenom poradí.
English: CA209205 Cohort Ba and CA209039
Slovak: CA209205 Kohorta Ba a CA209039 (n =
English: 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.
Slovak: Odpovede sa hodnotili pomocou RECIST 1.1 u 588/1 008 (58,3
English: Physicians should consider the delayed onset of nivolumab effect before initiating treatment in patients with poorer prognostic features and/or aggressive disease.
Slovak: Pred začatím liečby u pacientov s horšími prognostickými znakmi a/alebo agresívnym ochorením majú lekári zvážiť oneskorený nástup účinku nivolumabu.
English: This leaflet was last revised in
Slovak: OS sú uvedené na obrázku
English: Grade 2 cases were reported in 2.2% (10/448) of patients.
Slovak: % (2/448) pacientov.
English: Grade 3 and 4 cases were reported in 1.6% (41/2578) and 0.3% (9/2578) of patients, respectively.
Slovak: Prípady 3. stupňa sa hlásili u 1,6 % (41/2 578) a 4. stupňa u 0,3
English: docetaxel (n = 290)
Slovak: 292) alebo na docetaxel (n =
English: 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
Slovak: Celkovo bolo randomizovaných 582 pacientov, buď na intravenózne podávanie nivolumabu v dávke 3 mg/kg počas 60 minút každé 2 týždne (n =
English: 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).
Slovak: 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).
English: Resolution occurred in 192 patients (72.2%) with a median time to resolution of 11.6 weeks (range: 0.1-126.7+).
Slovak: %) s mediánom času do vyriešenia 11,6 týždňa (rozsah: 0,1-126,7+).
English: Rare (may affect up to 1 in 1000 people) Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis)
Slovak: Závažné a pravdepodobne smrteľné olupovanie kože (toxická epidermálna nekrolýza).
English: Tumour PD-L1 expression was determined using the PD-L1 IHC 288 pharmDx assay.
Slovak: Expresia PD-L1 v nádore sa stanovila pomocou medódy PD-L1
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of pneumonitis including interstitial lung disease, was 7.8% (35/448).
Slovak: U pacientov liečených nivolumabom v dávke 1 mg/kg v kombinácii s ipilimumabom v dávke 3 mg/kg pri melanóme bola incidencia pneumonitídy vrátane intersticiálneho ochorenia pľúc 7,8
English: Comparable to the overall population, median duration of response was increased with nivolumab vs. docetaxel for patients with no PD-L1 expression (18.3 months vs. 5.6 months) and for patients with PD-L1 expression (16.0 months vs. 5.6 months).
Slovak: V porovnaní s celkovou populáciou bol medián trvania odpovede predĺžený s nivolumabom oproti docetaxelu u pacientov bez expresie PD-L1
English: Inflammation of the liver
Slovak: Zápal pečene
English: Median time to onset was 1.2 months (range: 0.0-22.6).
Slovak: Medián času do nástupu bol 1,2 mesiaca (rozsah: 0,0-22,6).
English: HRb (95% CI)
Slovak: Výskyt (95 % CI)
English: Patients with a baseline performance score ≥ 2, active brain metastases or leptomeningeal metastases, autoimmune disease, and patients who had been receiving systemic immunosuppressants prior to study entry were excluded from the pivotal clinical trials of nivolumab or nivolumab in combination with ipilimumab (see sections 4.5 and 5.1).
Slovak: 2, aktívnymi metastázami v mozgu alebo leptomeningeálnymi metastázami, autoimunitným ochorením a pacienti, ktorí dostali systémové imunosupresíva pred zaradením do štúdie boli z pivotných klinických skúšaní s nivolumabom alebo s nivolumabom v kombinácii s ipilimumabom vylúčení (pozri časti 4.5 a 5.1).
English: Efficacy by tumour PD-L1 expression: Objective responses to nivolumab were observed regardless of tumour PD-L1 expression.
Slovak: Objektívne odpovede na nivolumab sa pozorovali bez ohľadu na expresiu PD-L1 v nádore.
English: Patients with any history of or concurrent brain metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the clinical trials of nivolumab or nivolumab in combination with ipilimumab (see sections 4.5 and 5.1).
Slovak: Pacienti so súbežnými metastázami v mozgu, aktívnym autoimunitným ochorením alebo zdravotnými stavmi vyžadujúcimi si systémovú imunosupresiu alebo s ich akoukoľvek anamnézou boli z klinických skúšaní s nivolumabom alebo s nivolumabom v kombinácii s ipilimumabom vylúčení (pozri časti 4.5 a 5.1).
English: Results from post-hoc, exploratory analyses indicate that in patients with low (e.g. <1%) to no tumour PD-L1 expression, other patient characteristics (e.g. liver metastases, visceral metastases, baseline haemoglobin <10g/dL and ECOG performance status = 1) might contribute to the clinical outcome.
Slovak: %) až žiadnou expresiou PD-L1 v nádore, inými charakteristikami pacienta (napr. metastázy v pečeni, viscerálne metastázy, východisková hladina hemoglobínu <
English: OS benefit was observed regardless of HPV status (HPV-positive: HR = 0.63; 95% CI: 0.38, 1.04, HPV-negative: HR = 0.64; 95% CI: 0.40, 1.03, and HPV-unknown: HR = 0.78; 95% CI: 0.55, 1.10).
Slovak: 0,64; 95 % CI: 0,40; 1,03 a HPV-neznámy: HR =
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of advanced or metastatic non-squamous NSCLC were evaluated in a phase 3, randomised, open-label study (CA209057).
Slovak: Bezpečnosť a účinnosť nivolumabu 3 mg/kg ako jedinej látky na liečbu pokročilého alebo metastatického neskvamózneho NSCLC sa hodnotili v randomizovanej, otvorenej štúdii 3. fázy (CA209057).
English: Patients with Karnofsky performance status < 70% and patients with any history of or concurrent brain metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the study.
Slovak: 70 % a pacienti so súbežnými metastázami v mozgu, s aktívnym autoimunitným ochorením alebo zdravotnými stavmi vyžadujúcimi si systémovú imunosupresiu alebo s ich akoukoľvek anamnézou boli zo štúdie vyradení.
English: The median age was 60 years (range: 28-83) with 31% ≥ 65 years of age and 5% ≥ 75 years of age, 83% were male, and 83% were white.
Slovak: % s vekom ≥ 65 rokov a 5 % s vekom ≥ 75 rokov, 83 % bolo mužov a 83 % bolo belochov.
English: Resolution occurred in 37 patients (77.1%) with a median time to resolution of 13.2 weeks (range: 0.1+-106.0+).
Slovak: %) s mediánom času do vyriešenia 13,2 týždňa (rozsah: 0,1+-106,0+).
English: ECOG performance status score was 0 (73%) or 1 (27%).
Slovak: Skóre výkonnostného stavu ECOG bolo 0 (73
English: Progression-free survival Median (95% CI) months Rate (95% CI) at 6 months
Slovak: Prežívanie bez progresie Medián (95 % CI) mesiace Výskyt (95 % CI) po 6 mesiacoch Celkové prežívanie Medián (95 % CI) mesiace
English: Nine of 49 patients (18.4%) died from complications of allogeneic HSCT after nivolumab.
Slovak: %) zomrelo na komplikácie alogénnej HSCT po podaní nivolumabu.
English: Median duration of response Months (range)
Slovak: Trvanie odpovede Medián (rozsah) mesiace
English: Resolution occurred in 21 patients (91.3%) with a median time to resolution of 2.1 weeks (range: 0.1- 125.1+).
Slovak: %) s mediánom času do vyriešenia 2,1 týždňa (rozsah: 0,1 - 125,1+).
English: For tumour PD-L1 expression < 1%, the median OS was 34.7 months for the nivolumab in combination with ipilimumab, and was 32.2 months in the sunitinib arm (HR = 0.70; 95% CI: 0.54, 0.92).
Slovak: % bol medián OS 34,7 mesiaca a v skupine so sunitinibom bol 32,2 mesiaca (HR =
English: Resolution occurred in 63 patients (72.4%) with a median time to resolution of 6.1 weeks (range: 0.1+-96.7+); + denotes a censored observation.
Slovak: %) s mediánom času do vyriešenia 6,1 týždňa (rozsah: 0,1+ - 96,7+);
English: Tabulated summary of adverse reactions
Slovak: Zoznam nežiaducich reakcií v tabuľke
English: Table 8: Efficacy Results (CA209066)
Slovak: OS (CA209066)
English: CA209205 Cohort Cb
Slovak: CA209205 Cohort