natgillin/translations-raw huggingface dataset:
86% havde en primær tumor i de nedre urinveje, og 14% havde en primær tumor i de øvre urinveje.
Eighty-six percent had a primary tumour in the lower tract and 14% had a primary tumour in the upper tract.
Sådan får du Keytruda
How you are given KEYTRUDA
Bedste samlede respons* bedømt ved IRO ORR %, (95% CI) Komplet respons Partielt respons Sygdomskontrolrate % Responsvarighed Median i måneder (interval) % igangværende i måned 24 PFS Median i måneder (95% CI) PFS-rate i måned 12 OS Median i måneder (95% CI)
Best Overall Response* by IRO ORR %, (95% CI) Complete response Partial response Disease Control Rate % Response Duration Median in months (range) % ongoing at 24 months PFS Median in months (95% CI) PFS rate at 12 months OS Median in months (95% CI)
Pembrolizumabs sikkerhed som monoterapi blev vurderet hos 154 pædiatriske patienter med fremskredent melanom, lymfom eller PD-L1-positive fremskredne, recidiverende eller refraktære solide tumorer ved en dosis på 2 mg/kg hver 3. uge i fase I/II-studiet KEYNOTE-051.
The safety of pembrolizumab as monotherapy has been evaluated in 154 paediatric patients with advanced melanoma, lymphoma, or PD-L1 positive advanced, relapsed, or refractory solid tumours at 2 mg/kg every 3 weeks in the Phase I/II study KEYNOTE-051.
Følgende bivirkninger er indberettet i kliniske studier med pembrolizumab i kombination med axitinib:
The following side effects have been reported in clinical trials with pembrolizumab in combination with axitinib:
• Keytruda må ikke administreres sammen med andre lægemidler i samme infusionsslange.
• Do not co-administer other medicinal products through the same infusion line.
Der er begrænsede data vedrørende forsøgspersoner med stadie IIIA i henhold til AJCC, 8. udgave, på tidspunktet for RFS-analysen.
There is limited data on subjects with stage IIIA according to AJCC 8
Pembrolizumab er ikke undersøgt hos patienter med svært nedsat nyrefunktion.
Pembrolizumab has not been studied in patients with severe renal impairment.
OS-raten i måned 18 var 81,0% (95% CI: 76,7; 84,6) for pembrolizumab i kombination med axitinib og 70,7% (95% CI: 65,8; 75,1) for sunitinib.
The 18-month OS rate was 81.0% (95% CI 76.7, 84.6) for pembrolizumab in combination with axitinib and 70.7% (95% CI 65.8, 75.1) for sunitinib.
Alle på nær en patient var kaukasere.
All but one patient was white.
For så vidt angår recidiverende eller refraktært klassisk Hodgkins lymfom foreligger der kun begrænsede kliniske data for anvendelse af pembrolizumab hos patienter, som er uegnede til ASCT af andre årsager end behandlingssvigt efter salvage-kemoterapi (se pkt.
For subjects with relapsed or refractory classical Hodgkin lymphoma, clinical data for the use of pembrolizumab in patients ineligible to ASCT due to reasons other than failure to salvage chemotherapy are limited (see section 5.1).
Patienterne blev randomiseret i forholdet 1:1:1 til at få pembrolizumab i en dosis på 2 mg/kg (n=344) eller 10 mg/kg (n=346) hver 3. uge eller docetaxel i en dosis på 75 mg/m2 hver 3. uge (n=343) indtil sygdomsprogression eller uacceptabel toksicitet.
Patients were randomised (1:1:1) to receive pembrolizumab at a dose of 2 (n=344) or 10 mg/kg (n=346) every 3 weeks or docetaxel at a dose of 75 mg/m2 every 3 weeks (n=343) until disease progression or unacceptable toxicity.
KG Birkendorfer Straße 65 88397 Biberach an der Riss Tyskland
Boehringer Ingelheim (BIB) Pharma GmbH & Co. KG Birkendorfer Straße 65 88397 Biberach an der Riss Germany
Armen med pembrolizumab som monoterapi forbliver kun åben for patienter, hvis tumorer udtrykker PD-L1 med CPS ≥ 10.
The pembrolizumab monotherapy arm remains open only to patients whose tumours express PD-L1 with a CPS ≥ 10.
Pembrolizumabs virkning i kombination med pemetrexed og platinbaseret kemoterapi blev undersøgt i et randomiseret, aktivt kontrolleret, dobbeltblindet multicenterstudie, KEYNOTE-189.
The efficacy of pembrolizumab in combination with pemetrexed and platinum chemotherapy was investigated in a multicentre, randomised, active-controlled, double-blind trial, KEYNOTE-189.
(KEYNOTE-087) / 8. uge (KEYNOTE-013) med den første planlagte vurdering efter baseline i uge 12.
Response was assessed in KN087 and KN013 every 12 and 8 weeks, respectively, with the first planned post-baseline assessment at week 12.
Antal i risikogruppe Pembrolizumab + Axitinib:
Number at Risk Pembrolizumab + Axitinib:
Middel risiko Høj risiko Bekræftet ORR
Confirmed ORR
Følgende bivirkninger er indberettet med pembrolizumab alene:
The following side effects have been reported with pembrolizumab alone:
I denne patientpopulation var de hyppigste bivirkninger: diarré (54%), hypertension (45%), træthed (38%), hypotyroidisme (35%), appetitløshed (30%), palmoplantar erytrodysæstesisyndrom (hånd-fod-syndrom) (28%), kvalme (28%), forhøjet ALAT (27%), forhøjet ASAT (26%), dysfoni (25%), hoste (21%) og obstipation (21%).
In this patient population, the most frequent adverse reactions were diarrhoea (54%), hypertension (45%), fatigue (38%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysaesthesia syndrome (28%), nausea (28%), ALT increased (27%), AST increased (26%), dysphonia (25%), cough (21%), and constipation (21%).
Pembrolizumab-doser på 2 mg/kg hver 3. uge, 10 mg/kg hver 3. uge og 10 mg/kg hver 2. uge blev vurderet i kliniske studier af melanom-patienter eller NSCLC-patienter, som tidligere har været behandlet.
Pembrolizumab doses of 2 mg/kg every 3 weeks, 10 mg/kg every 3 weeks, and 10 mg/kg every 2 weeks were evaluated in melanoma or previously treated NSCLC clinical trials.
KEYNOTE-426: Kontrolleret studie af kombinationsbehandling hos behandlingsnaive RCC-patienter Pembrolizumabs virkning i kombination med axitinib blev undersøgt i KEYNOTE-426, et randomiseret, åbent, aktivt kontrolleret multicenterstudie hos patienter med fremskredent RCC med en clear cellkomponent, uanset PD-L1-tumorekspressionsstatus og risikogruppekategorier i henhold til IMDC (International Metastatic RCC Database Consortium).
Renal cell carcinoma KEYNOTE-426: Controlled trial of combination therapy in RCC patients naïve to treatment The efficacy of pembrolizumab in combination with axitinib was investigated in KEYNOTE-426, a randomised, multicentre, open-label, active-controlled trial conducted in patients with advanced RCC with clear cell component, regardless of PD-L1 tumour expression status and International Metastatic RCC Database Consortium (IMDC) risk group categories.
I tabel 13 opsummeres de vigtigste effektresultater.
Table 13 summarises key efficacy measures.
Figur 10: Kaplan-Meier-kurve for progressionsfri overlevelse i KEYNOTE-407
Figure 10: Kaplan-Meier Curve for Progression-Free Survival in KEYNOTE-407
Mistanke om pneumonitis skal bekræftes ved en billeddiagnostisk udredning af patienterne, og andre årsager skal udelukkes.
Suspected pneumonitis should be confirmed with radiographic imaging and other causes excluded.
KEYTRUDA som monoterapi er indiceret til behandling af recidiverende eller refraktært klassisk Hodgkins lymfom (cHL) hos voksne, som har oplevet svigt af autolog stamcelletransplantation (ASCT) og svigt af behandling med brentuximab vedotin (BV), eller som er uegnede til transplantation og har oplevet svigt af behandling med BV.
KEYTRUDA as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.
For IMDC-risikokategorien: HR for OS for risikogruppen med lav risiko var 0,94 (95% CI: 0,43; 2,07), HR for OS for risikogruppen med middel risiko var 0,52 (95% CI: 0,36; 0,75) og HR for OS for risikogruppen med høj risiko var 0,50 (95% CI: 0,29; 0,87).
For the IMDC risk category, the OS hazard ratio for the favourable risk group was 0.94 (95% CI 0.43, 2.07), for the intermediate risk group the OS hazard ratio was 0.52 (95% CI 0.36, 0.75), and for the poor risk group the OS hazard ratio was 0.50 (95% CI 0.29, 0.87).
Kemoterapi (n=137)
Chemotherapy (n=137)
I KEYNOTE-051 blev pembrolizumab 2 mg/kg hver 3. uge administreret til 154 pædiatriske patienter (60 børn i alderen 6 måneder til under 12 år og 94 unge i alderen 12 år til 18 år) med fremskredent melanom eller PD-L1-positive fremskredne, recidiverende eller refraktære solide tumorer eller lymfomer.
In KEYNOTE-051, 154 paediatric patients (60 children aged 6 months to less than 12 years and 94 adolescents aged 12 years to 18 years) with advanced melanoma or PD-L1 positive advanced, relapsed, or refractory solid tumours or lymphoma were administered pembrolizumab 2 mg/kg every 3 weeks.
Antal i risikogruppe Pembrolizumab:
Number at Risk Pembrolizumab:
82% havde melanom i M1c-stadiet, 73% af patienterne havde forudgående fået mindst to, og 32% af patienterne havde fået tre eller flere systemiske behandlingsregimer for fremskredent melanom.
Eighty-two percent had M1c stage, 73% had at least two and 32% of patients had three or more prior systemic therapies for advanced melanoma.
Tabel 13: Effektresultater i KEYNOTE-189
Table 13: Efficacy results in KEYNOTE-189
Af de 51 patienter, som fik 2 mg/kg pembrolizumab, og som ikke tidligere havde været behandlet med ipilimumab, var 63% mænd, 35% var ≥ 65 år, og medianalderen var 60 år (interval: 35-80).
Of the 51 patients receiving 2 mg/kg of pembrolizumab who were naïve to treatment with ipilimumab, 63% were male, 35% were ≥ 65 years of age and the median age was 60 years (range 35-80).
Hos patienter med ikkeplanocellulær NSCLC, som fik pembrolizumab i kombination med pemetrexed og platinbaseret kemoterapi (n=488), var forekomsten af nefritis 1,4% (alle grader) med 0,8% af grad 3 og 0,4% af grad 4.
In patients with non-squamous NSCLC treated with pembrolizumab in combination with pemetrexed and platinum chemotherapy (n=488), the incidence of nephritis was 1.4% (all Grades) with 0.8% Grade 3 and 0.4% Grade 4.
• Før rekonstitution kan hætteglasset med frysetørret pulver (lyofilisat) opbevares uden for køleskab (ved temperaturer på eller under 25 °C) i op til 24 timer.
• Prior to reconstitution, the vial of lyophilised powder can be out of refrigeration (temperatures at or below 25°C) for up to 24 hours.
De sekundære resultatmål var samlet responsrate (ORR) og responsvarighed.
Secondary efficacy outcome measures were overall response rate (ORR) and response duration.
Ud af 834 patienter var 60% mænd, 44% var ≥ 65 år (medianalder 62 år [interval: 18-89]), og 98% var kaukasere.
Of the 834 patients, 60% were male, 44% were ≥ 65 years (median age was 62 years [range 18-89]) and 98% were white.
81% var refraktære over for mindst en forudgående behandling, inklusive 35%, som var refraktære over for førstelinjebehandling.
Eighty-one percent were refractory to at least one prior therapy, including 35% who were refractory to first line therapy.
84% var refraktære over for mindst en forudgående behandling, inklusive 35%, som var refraktære over for førstelinjebehandling.
Eighty-four percent were refractory to at least one prior therapy, including 35% who were refractory to first line therapy.
Kaplan-Meier-kurver for OS og PFS er vist i figur 9 og 10.
The Kaplan-Meier curves for OS and PFS are shown in Figures 9 and 10.
Pembrolizumabs virkning blev vurderet i KEYNOTE-054, et randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie hos patienter med komplet resekteret stadie IIIA- (> 1 mm lymfeknudemetastaser), IIIB- eller IIIC-melanom.
The efficacy of pembrolizumab was evaluated in KEYNOTE-054, a multicentre, randomised, doubleblind, placebo-controlled trial in patients with completely resected stage IIIA (> 1 mm lymph node metastasis), IIIB or IIIC melanoma.
Figur 9: Kaplan-Meier-kurve for samlet overlevelse i KEYNOTE-407
Figure 9: Kaplan-Meier Curve for Overall Survival in KEYNOTE-407
Vejledning til håndtering af disse bivirkninger findes i pkt.
The management guidelines for these adverse reactions are described in section 4.4.
De centrale inklusionskriterier var metastatisk ikke-planocellulær NSCLC, ingen tidligere systemisk behandling for metastatisk NSCLC og ingen EGFR- eller ALK-mutationer i tumor.
Key eligibility criteria were metastatic non-squamous NSCLC, no prior systemic treatment for metastatic NSCLC, and no EGFR or ALK genomic tumour aberrations.
Patienterne blev randomiseret i forholdet 1:1:1 til at få pembrolizumab i en dosis på 2 (n=180) eller 10 mg/kg (n=181) hver 3. uge eller kemoterapi (n=179; inkluderede dacarbazin, temozolomid, carboplatin, paclitaxel eller carboplatin+paclitaxel).
Patients were randomised (1:1:1) to receive pembrolizumab at a dose of 2 (n=180) or 10 mg/kg (n=181) every 3 weeks or chemotherapy (n=179; including dacarbazine, temozolomide, carboplatin, paclitaxel, or carboplatin+paclitaxel).
Kaplan-Meierkurver for OS og PFS, som er baseret på den endelige analyse, er vist i figur 1 og 2.
Kaplan-Meier curves for OS and PFS based on the final analysis are shown in Figures 1 and 2.
Ikke almindelig neutropeni, leukopeni, eosinofili lymfopeni, eosinofili
Uncommon neutropaenia, leukopaenia, eosinophilia lymphopaenia, eosinophilia
Pembrolizumabs farmakokinetik blev undersøgt hos 2.993 patienter med metastatisk eller inoperabelt melanom, NSCLC eller karcinom, som har fået doser i intervallet 1 til 10 mg/kg hver 2. uge, 2 til 10 mg/kg hver 3. uge eller 200 mg hver 3. uge.
The pharmacokinetics of pembrolizumab was studied in 2,993 patients with metastatic or unresectable melanoma, NSCLC, or carcinoma who received doses in the range of 1 to 10 mg/kg every 2 weeks, 2 to 10 mg/kg every 3 weeks, or 200 mg every 3 weeks.
Patienterne skal behandles med KEYTRUDA indtil sygdomsprogression eller uacceptabel toksicitet.
Patients should be treated with KEYTRUDA until disease progression or unacceptable toxicity.
Kaplan-Meier-kurver for OS og PFS er vist i figur 7 og 8.
The Kaplan-Meier curves for OS and PFS are shown in Figures 7 and 8.
Den mediane opfølgningstid var 10,5 måneder (interval: 0,2 til 20,4 måneder).
The median follow-up time was 10.5 months (range: 0.2 to 20.4 months).
BRAF-mutation med forudgående BRAFbehandling
BRAF mutant with prior BRAF treatment
Ikke almindelig likenoid keratose u, psoriasis, dermatitis, papel, ændret hårfarve psoriasis, akneiform dermatitis, dermatitis, vitiligo t, eksem ændret hårfarve, likenoid keratose, papel, psoriasis, vitiligo
Uncommon lichenoid keratosis u, psoriasis, dermatitis, papule, hair colour changes psoriasis, dermatitis acneiform, dermatitis, vitiligo t, eczema hair colour changes, lichenoid keratosis, papule, psoriasis, vitiligo
Patienter med nasofaryngealt karcinom, aktiv autoimmun sygdom, der havde krævet systemisk behandling inden for 2 år efter behandling, eller lidelser, som krævede behandling med immunsuppressiva, var uegnede til studiet.
Patients with nasopharyngeal carcinoma, active autoimmune disease that required systemic therapy within two years of treatment or a medical condition that required immunosuppression were ineligible for the study.
Effekten af nedsat nyrefunktion på pembrolizumabs clearance blev vurderet ud fra farmakokinetiske populationsanalyser, hvor patienter med let eller moderat nedsat nyrefunktion blev sammenlignet med patienter med normal nyrefunktion.
The effect of renal impairment on the clearance of pembrolizumab was evaluated by population pharmacokinetic analyses in patients with mild or moderate renal impairment compared to patients with normal renal function.
Pembrolizumabs sikkerhed i kombination med kemoterapi er blevet vurderet hos 1.067 patienter med NSCLC eller HNSCC, der fik 200 mg, 2 mg/kg eller 10 mg/kg pembrolizumab hver 3. uge, i kliniske studier.
The safety of pembrolizumab in combination with chemotherapy has been evaluated in 1,067 patients with NSCLC or HNSCC receiving 200 mg, 2 mg/kg or 10 mg/kg pembrolizumab every 3 weeks, in clinical studies.
Der blev udført en subgruppeanalyse som en del af den endelige analyse i KEYNOTE-002 hos patienter, som havde BRAF vildtype (n=414; 77%) eller BRAF-mutation med forudgående BRAF-behandling (n=126; 23%) som opsummeret i tabel 6.
A subgroup analysis was performed as part of the final analysis of KEYNOTE-002 in patients who were BRAF wild type (n=414; 77%) or BRAF mutant with prior BRAF treatment (n=126; 23%) as summarised in Table 6.
Den anbefalede dosis af KEYTRUDA som monoterapi er enten 200 mg hver 3. uge eller 400 mg hver 6. uge administreret som intravenøs infusion over 30 minutter.
The recommended dose of KEYTRUDA as monotherapy is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes.
KEYTRUDA som monoterapi eller i kombination med platinbaseret kemoterapi og 5-fluorouracil (5-FU) er indiceret til førstelinjebehandling af metastatisk eller inoperabelt recidiverende planocellulært hovedhals karcinom (HNSCC) hos voksne, hvis tumorer udtrykker PD-L1 med CPS ≥ 1 (se pkt.
KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1 (see section 5.1).
Stadie IIIA-melanom i henhold til AJCC, 8. udgave, identificerer en patientpopulation med en bedre prognose sammenlignet med stadie IIIA i henhold til AJCC, 7. udgave.
th edition identifies a patient population with a better prognosis compared to stage IIIA according to AJCC 7
Nefritis gik over hos 13 patienter, 3 med sequelae.
Nephritis resolved in 13 patients, 3 with sequelae.
Følgende bivirkninger er indberettet i kliniske studier med pembrolizumab i kombination med kemoterapi:
The following side effects have been reported in clinical trials with pembrolizumab in combination with chemotherapy:
Blandt de 882 patienter i KEYNOTE-048, havde 754 (85%) tumorer, som udtrykte PD-L1 med CPS ≥ 1 baseret på PD-L1 IHC 22C3 pharmDx™-analysen.
Among the 882 patients in KEYNOTE-048, 754 (85%) had tumours that expressed PD-L1 with a CPS ≥ 1 based on the PD-L1 IHC 22C3 pharmDx
Ikke almindelig hepatitis hepatitis
Uncommon hepatitis hepatitis
OS-raten i måned 12 var 89,5% (95% CI: 86,2; 92,1) for pembrolizumab i kombination med axitinib og 78,8% (95% CI: 74,7; 82,4) for sunitinib.
The 12-month OS rate was 89.5% (95% CI 86.2, 92.1) for pembrolizumab in combination with axitinib and 78.8% (95% CI 74.7, 82.4) for sunitinib.
Medianvarigheden var 2,6 måneder (interval: 6 dage til 12,0 måneder).
The median duration was 2.6 months (range 6 days to 12.0 months).
Hypofysitis gik over hos 17 patienter, 8 med sequelae.
Hypophysitis resolved in 17 patients, 8 with sequelae.
Hud og subkutane væv Meget almindelig udslæt q, pruritus udslæt q, alopeci, pruritus palmoplantar erytrodysæstesisyndrom (hånd-fod-syndrom), udslæt q, pruritus
Skin and subcutaneous tissue disorders Very common rash q, pruritus rash q, alopecia, pruritus palmar-plantar erythrodysaesthesia syndrome, rash q,
ORR-forskel, % (95% CI)
ORR difference, % (95% CI)
Pembrolizumabs sikkerhed som monoterapi er blevet vurderet hos 5.884 patienter med fremskredent melanom, resekteret stadie III-melanom (adjuverende behandling), NSCLC, cHL, urotelialt karcinom eller HNSCC ved 4 doser (2 mg/kg hver 3. uge, 200 mg hver 3. uge eller 10 mg/kg hver 2. eller 3. uge) i kliniske studier.
The safety of pembrolizumab as monotherapy has been evaluated in 5,884 patients with advanced melanoma, resected Stage III melanoma (adjuvant therapy), NSCLC, cHL, urothelial carcinoma, or HNSCC across four doses (2 mg/kg every 3 weeks, 200 mg every 3 weeks, or 10 mg/kg every 2 or 3 weeks) in clinical studies.
Ved forhøjede leverenzymer hos RCC-patienter, der behandles med KEYTRUDA i kombination med axitinib:
For liver enzyme elevations, in patients with RCC being treated with KEYTRUDA in combination with axitinib:
Hos patienter med HNSCC, som blev behandlet med pembrolizumab som monoterapi (n=909), var forekomsten af hypotyroidisme 16,1% (alle grader) med 0,3% af grad 3.
In patients with HNSCC treated with pembrolizumab as monotherapy (n=909), the incidence of hypothyroidism was 16.1% (all Grades) with 0.3% Grade 3.
Forhøjede leverenzymer, når pembrolizumab anvendes i kombination med axitinib ved RCC I et klinisk studie af tidligere ubehandlede RCC-patienter, der fik pembrolizumab i kombination med axitinib, blev der observeret en højere end forventet forekomst af grad 3 og 4 forhøjelser af ALAT (20%) og ASAT (13%).
Elevated liver enzymes when pembrolizumab is combined with axitinib in RCC In a clinical study of previously untreated patients with RCC receiving pembrolizumab in combination with axitinib, a higher than expected incidence of Grades 3 and 4 ALT increased (20%) and AST increased (13%) were observed.
Pneumonitis medførte seponering af pembrolizumab hos 98 (1,7%) patienter.
Pneumonitis led to discontinuation of pembrolizumab in 98 (1.7%) patients.
Den mediane tid til indtræden af pneumonitis var 3,3 måneder (interval: 2 dage til 26,8 måneder).
The median time to onset of pneumonitis was 3.3 months (range 2 days to 26.8 months).
Almindelig influenzalignende sygdom, kuldegysninger kuldegysninger, influenzalignende sygdom ødem aa
Common influenza like illness, chills chills, influenza-like illness oedema aa
Ud af 540 patienter var 61% mænd, 43% var ≥ 65 år (medianalderen var 62 år [interval: 15-89]), og 98% var kaukasere.
Of the 540 patients, 61% were male, 43% were ≥ 65 years (median age was 62 years [range 15-89]) and 98% were white.
Baseline-karakteristika for denne population inkluderede: medianalder 63 år (42% i alderen 65 år eller ældre); 61% mænd; 72% kaukasere og 21% asiater og henholdsvis 34% og 66% med ECOGperformance-status 0 og 1.
The baseline characteristics for this population included: median age 63 years (42% age 65 or older); 61% male; 72% White and 21% Asian and 34% and 66% with an ECOG performance status 0 and 1, respectively.
Colitis gik over hos 84 patienter, 2 med sequelae.
Colitis resolved in 84 patients, 2 with sequelae.
Tabel 17: Respons på pembrolizumab 2 eller 10 mg/kg hver 3. uge hos tidligere behandlede patienter med NSCLC i KEYNOTE-010
Table 17: Response to pembrolizumab 2 or 10 mg/kg every 3 weeks in previously treated patients with NSCLC in KEYNOTE-010
• Før fortynding kan hætteglasset med koncentrat opbevares uden for køleskab (ved temperaturer på eller under 25 °C) i op til 24 timer.
• Prior to dilution, the vial of liquid can be out of refrigeration (temperatures at or below 25°C) for up to 24 hours.
I tabel 9 opsummeres effektresultaterne ud fra PD-L1-ekspression.
Table 9 summarizes efficacy results by PD-L1 expression.
Kemoterapi (n=42)
Chemotherapy (n=42)
Medianvarigheden blev ikke nået (interval: 2 dage til 32,6+ måneder).
The median duration was not reached (range 2 days to 32.6+ months).
Medianvarigheden var 3,3 måneder (interval: 3 dage til 18,1+ måneder).
The median duration was 3.3 months (range 3 days to 18.1+ months).
Almindelig svimmelhed, perifer neuropati, letargi, dysgeusi letargi svimmelhed, letargi, perifer neuropati
Common dizziness, neuropathy peripheral, lethargy, dysgeusia lethargy dizziness, lethargy, neuropathy peripheral
I tabel 8 opsummeres effektresultaterne ud fra PD-L1-ekspression.
Table 8 summarises efficacy results by PD-L1 expression.
81% havde en primær tumor i den nederste del af urinvejene, og 19% havde en primær tumor i de øvre urinveje.
Eighty-one percent had a primary tumour in the lower tract, and 19% of patients had a primary tumour in the upper tract.
Patienterne blev randomiseret i forholdet 1:1 til en af følgende behandlingsarme med intravenøs infusion:
Patients were randomised (1:1) to one of the following treatment arms via intravenous infusion:
Standardbehandling* n=110
Standard Treatment* n=110