FrancophonIA/ELRC3.0 huggingface dataset:
English: Twenty-one patients with previously untreated and 12 patients with previously treated advanced ALK-positive non-adenocarcinoma histology NSCLC were enrolled in randomised Phase 3 Studies 1014 and 1007, respectively.
Danish: 21 patienter med tidligere ubehandlet og 12 patienter med tidligere behandlet ALK-positiv NSCLC med non-adenokarcinom histologi blev inkluderet i de randomiserede fase 3-studier, henholdsvis 1014 og 1007.
English: The central tendency analysis indicated that the largest mean change from baseline in QTcF was 12.3 msec (95% CI 5.1-19.5 msec, least squares mean [LS] from Analysis of Variance [ANOVA]) and occurred at 6 hours post-dose on Cycle 2 Day 1.
Danish: Den centrale tendensanalyse tydede på, at den største middelændring af QTcF fra baseline var 12,3 ms (95% CI 5,1-19,5 ms, gennemsnit efter mindste kvadraters metode [LS] fra variansanalyse [ANOVA]), som forekom 6 timer efter dosering på dag 1 i cyklus 2.
English: • Dabigatran, anticoagulant used to slow down clotting of the blood.
Danish: • Dabigatran, får blodet til at størkne langsommere.
English: Your doctor may do blood tests to check your liver function, and if the results are abnormal, your doctor may decide to reduce the dose of XALKORI or stop your treatment.
Danish: For at kontrollere leverfunktionen vil lægen tage blodprøver, og hvis værdierne er for høje, kan det være nødvendigt, at lægen sætter dosis af XALKORI ned eller stopper behandlingen.
English: All-causality bradycardia was reported in clinical studies in 13% of patients treated with crizotinib.
Danish: I kliniske studier sås bradykardi af enhver årsag hos 13% af de patienter, der blev behandlet med crizotinib.
English: j. Abdominal pain (Abdominal discomfort, Abdominal pain, Abdominal pain lower, Abdominal pain upper, Abdominal tenderness).
Danish: j) Abdominalsmerter (abdominalt ubehag, abdominalsmerter, smerter i nedre abdomen, smerter i øvre abdomen,
English: The effect of renal function as measured by baseline CLcr on observed crizotinib steady-state trough concentrations (Ctrough, ss) was evaluated.
Danish: Nyrefunktionens indvirkning på de observerede trough-koncentrationer af crizotinib (Ctrough, ss) ved steady state blev vurderet ud fra baseline CLcr.
English: PVC-foil blisters containing 10 hard capsules.
Danish: PVC-folieblister indeholdende 10 hårde kapsler.
English: Nausea (57%), diarrhoea (54%), vomiting (51%), and constipation (43%) were the most commonly reported all-causality gastrointestinal events.
Danish: Kvalme (57%), diarré (54%), opkastning (51%) og obstipation (43%) var de hyppigst indberettede bivirkninger fra mave-tarm-kanalen (uanset kausalitet).
English: The concomitant use of crizotinib with strong CYP3A4 inhibitors or with strong and moderate CYP3A4 inducers should be avoided (see section 4.5).
Danish: Administration af crizotinib sammen med potente CYP3A4-hæmmere eller sammen med potente eller moderate3A4 induktorer bør undgås (se pkt.
English: Of 172 ALK-positive patients treated with crizotinib in randomised Phase 3 Study 1007, 27 (16%) were 65 years or older.
Danish: Af de 172 ALKpositive patienter, der blev behandlet med crizotinib i det randomiserede fase 3-studie 1007, var 27 (16%) 65 år eller ældre.
English: Other potential causes of ILD/pneumonitis should be excluded (see sections 4.2 and 4.4).
Danish: Andre mulige årsager til ILD/pneumonitis skal udelukkes (se pkt.
English: If you have any questions about how XALKORI works or why this medicine has been prescribed for you, ask your doctor.
Danish: Kontakt lægen, hvis du har spørgsmål om, hvordan XALKORI virker, eller hvorfor du har fået denne medicin.
English: For patients without baseline brain metastases, the median IC-TTP was not reached in either the crizotinib (N=132) or the chemotherapy arms (N=131) (HR=0.69 [95% CI: 0.33, 1.45]; 1-sided p-value=0.1617).
Danish: Hos patienter uden hjernemetastaser ved baseline blev mediantiden for IC-TTP ikke nået hverken i crizotinib-armen (N=132) eller kemoterapi-armen (N=131) (HR=0,69 [95% CI: 0,33, 1,45]; 1-sidet p = 0,1617).
English: A total of 166 patients in the crizotinib arm and 163 patients in the chemotherapy arm had completed the EORTC QLQ-C30 and LC13 questionnaires at baseline and at least 1 postbaseline visit.
Danish: I alt 166 patienter i crizotinibarmen og 163 patienter i kemoterapi-armen havde udfyldt spørgeskemaerne EORTC QLQ-C30 og LC13 ved baseline og ved mindst 1 besøg efter baseline.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MAH logo)
Danish: Pfizer Europe MA EEIG (som MAH-logo)
English: Rash (13%)
Danish: Udslæt (13%)
English: Crizotinib is an inhibitor of OCT1 and OCT2 in vitro.
Danish: Crizotinib er en hæmmer af organisk kationtransporter 1 og 2 (OCT1 og OCT2) in vitro.
English: Abbreviations: CI=confidence interval; HR=hazard ratio; IRR=independent radiology review; N/n=number of patients; PFS=progression-free survival; OS=overall survival.
Danish: Forkortelser: CI = konfidensinterval; HR = risikorate (hazard ratio); IRR = uafhængig radiologisk gennemgang (Independent Radiology Review; N/n = antal patienter; PFS = progressionsfri overlevelse (Progression-free Survival); OS = samlet overlevelse (Overall Survival).
English: For ALK-positive NSCLC patients in Studies 1001 (N=154) and 1005 (N=1063), the median duration of treatment was 57 and 45 weeks, respectively.
Danish: For ALK-positive NSCLC-patienter i studie 1001 (N=154) og 1005 (N=1.063) var den mediane behandlingsvarighed hhv. 57 og 45 uger.
English: These medicines should be avoided during your treatment with XALKORI.
Danish: Du skal undgå ovenstående medicin under behandlingen med XALKORI.
English: CTCAEa Grade
Danish: CTCAE c-grad
English: Progression-Free Survival (Based on IRR) Number with event, n (%) Median PFS in months (95% CI)
Danish: Progressionsfri overlevelse (baseret på IRR) Antal med hændelse, n (%) Median PFS i måneder (95% CI)
English: All-causality neuropathy, as defined in Table 3, was experienced by 435 (25%) out of 1722 patients treated with crizotinib.
Danish: Neuropati af enhver årsag, som defineret i skema 3, blev set hos 435 (25%) af de 1.722 patienter, der blev behandlet med crizotinib.
English: There are no data in pregnant women using crizotinib.
Danish: Der er ingen data fra kliniske studier for anvendelse af crizotinib under graviditet.
English: Efficacy data from ROS1-positive advanced NSCLC patients from Study 1001 are provided in Table 7.
Danish: Effektdata fra patienter med ROS1-positiv fremskreden NSCLC i studie 1001 er anført i Skema 7.
English: After a single 250 mg dose in subjects with severe renal impairment (CLcr <30 mL/min) not requiring peritoneal dialysis or haemodialysis, crizotinib AUCinf and Cmax increased by 79% and 34%, respectively, compared to those with normal renal function.
Danish: Efter en enkeltdosis på 250 mg hos forsøgspersoner med svært nedsat nyrefunktion (CLcr < 30 ml/min), som ikke krævede peritonealdialyse eller hæmodialyse, var crizotinib-AUCinf og -Cmax øget med henholdsvis 79% og 34%, sammenlignet med patienter med normal nyrefunktion.
English: • Pilocarpine, used to treat glaucoma (a severe eye disease).
Danish: • Pilocarpin, til behandling af forhøjet tryk i øjet (grøn stær - en alvorlig øjensygdom).
English: Limited information is available in patients with ALK-positive and ROS1-positive NSCLC with non-adenocarcinoma histology, including squamous cell carcinoma (SCC) (see section 5.1).
Danish: Der er få tilgængelige data fra patienter med ALK-positiv og ROS1-positiv NSCLC med nonadenokarcinom-histologi, herunder planocellulært karcinom (SCC) (se pkt.
English: HDPE bottles with a polypropylene closure containing 60 hard capsules.
Danish: HDPE beholder med polypropylenlåg indeholdende 60 hårde kapsler.
English: Of the 53 ROS1-positive NSCLC patients in single arm Study 1001, 15 (28%) were 65 years or older.
Danish: Af de 53 ROS1-positive NSCLC-patienter i enkeltarmsstudie 1001 var 15 (28%) 65 år eller ældre.
English: Of 171 ALK-positive NSCLC patients treated with crizotinib in randomised Phase 3 Study 1014, 22 (13%) were 65 years or older, and of 109 ALK-positive patients treated with crizotinib who crossed over from chemotherapy arm, 26 (24%) were 65 years or older.
Danish: Af de 171 ALK-positive NSCLC-patienter, der blev behandlet med crizotinib i det randomiserede fase 3-studie 1014, var 22 (13%) 65 år eller ældre, og af de 109 ALK-positve patienter, der blev behandlet med crizotinib, og som overgik fra kemoterapi-armen, var 26 (24%) 65 år eller ældre.
English: Therefore, the concomitant use of crizotinib with medicinal products known to prolong QT interval or medicinal products able to induce Torsades de pointes (e.g., class IA [quinidine, disopyramide] or class III [e.g., amiodarone, sotalol, dofetilide, ibutilide], methadone, cisapride, moxifloxacine, antipsychotics, etc.) should be carefully considered.
Danish: Derfor bør samtidig brug af crizotinib og lægemidler, der kan forlænge QT-intervallet eller inducere Torsade de pointes (fx klasse IA [chinidin, disopyramid] eller klasse III [fx amiodaron, sotalol, dofetilid, ibutilid], methadon, cisaprid, moxifloxacin, antipsykotika etc.) overvejes nøje.
English: Number of deaths, n (%) Overall Survivalc [median (95% CI)] months
Danish: Antal dødsfald, n (%) Samlet overlevelse c [median (95% CI)] måneder
English: Fifty-eight of 84 (69%) patients treated with crizotinib and 17 of 119 (14%) patients treated with chemotherapy continued treatment for at least 3 weeks after objective disease progression.
Danish: 58 ud af 84 (69%) patienter, der blev behandlet med crizotinib, og 17 ud af 119 (14%) patienter, der fik kemoterapi, fortsatte med behandlingen i mindst 3 uger efter objektiv sygdomsprogression.
English: The systemic crizotinib exposure parameters AUCdaily and Cmax in patients with severe hepatic impairment (N=6) receiving a crizotinib dose of 250 mg once daily were approximately 64.7% and 72.6%, respectively, of those from patients with normal hepatic function receiving a dose of 250 mg twice daily.
Danish: Parametrene AUCdaily og Cmax for systemisk crizotinib-eksponering hos patienter med svært nedsat leverfunktion (N=6), som fik en crizotinib-dosis på 250 mg en gang daglig, var henholdsvis cirka 64,7% og 72,6%, sammenlignet med parametrene hos patienter med normal leverfunktion, som fik en dosis på 250 mg to gange dagligt.
English: e. Estimated using the Kaplan-Meier method.
Danish: e. Estimeret ved Kaplan-Meier-metoden.
English: In vitro studies indicated that clinical drug-drug interactions are unlikely to occur as a result of crizotinib-mediated inhibition of the metabolism of medicinal products that are substrates for CYP1A2, CYP2C8, CYP2C9, CYP2C19 or CYP2D6.
Danish: In vitro studier antyder, at det ikke er sandsynligt, at der vil være interaktion som følge af crizotinib-medieret hæmning af metaboliseringen af lægemidler, som er substrat for CYP1A2, CYP2C8, CYP2C9, CYP2C19 eller CYP2D6.
English: Optic atrophy and optic nerve disorder have been reported as potential causes of vision loss (see section 4.4).
Danish: Optisk atrofi og synsnervelidelse er blevet rapporteret som mulige årsager til synstab (se pkt.
English: Table 6: ALK-positive advanced NSCLC efficacy results from Studies 1001 and 1005 Efficacy Parameter
Danish: ALK-positiv fremskreden NSCLC effektdata fra studie 1001 og 1005 Virkningsparameter
English: Nervous system effects
Danish: Påvirkning af nervesystemet
English: Patients randomised to chemotherapy could cross over to receive crizotinib upon RECIST-defined disease progression confirmed by independent radiology review (IRR).
Danish: De patienter, der var randomiseret til kemoterapi, kunne overgå til crizotinibbehandling efter sygdomsprogression som defineret i RECIST og bekræftet ved en uafhængig radiologisk gennemgang (Independent Radiology Review - IRR).
English: Decreased bone formation in growing long bones was observed in immature rats at 150 mg/kg/day following once daily dosing for 28 days (approximately 3.3 times human clinical exposure based on AUC).
Danish: Der blev set nedsat knogledannelse i rørknoglerne hos ikke-færdigudviklede rotter ved doser på 150 mg/kg/dag efter en daglig dosering i 28 dage (ca. 3,3 gange human klinisk eksponering baseret på AUC).
English: Following single doses of crizotinib, the apparent plasma terminal half-life of crizotinib was 42 hours in patients.
Danish: Den terminale plasmahalveringstid for en enkeltdosis crizotinib er 42 timer.
English: • Irinotecan, a chemotherapy drug used to treat cancer of the colon and rectum.
Danish: • Irinotecan, til behandling af kræft i tyktarm og endetarm.
English: Complete blood counts including differential white blood cell counts should be monitored as clinically indicated, with more frequent repeat testing if Grade 3 or 4 abnormalities are observed, or if fever or infection occurs (see section 4.2).
Danish: Fuldstændig blodtælling inklusive differentialtælling af hvide blodlegemer bør foretages, når det er klinisk påkrævet, med hyppigere gentestning ved afvigelser af sværhedsgrad 3 og 4, eller i tilfælde af feber eller infektion (se pkt.
English: Capsule shell: gelatin, titanium dioxide (E171), and red iron oxide (E172).
Danish: Kapselskal indeholder: gelatine, titaniumdioxid (E171) og rød jernoxid (E172).
English: • Abnormalities in liver blood tests.
Danish: • Unormale blodprøveresultater for leverfunktionen.
English: Drug-induced hepatotoxicity with fatal outcome occurred in 0.1% of 1722 patients treated with crizotinib across clinical trials.
Danish: Der er set lægemiddelinduceret levertoksicitet med dødelig udgang hos 0,1% ud af 1.722 patienter i alle kliniske studier under behandling med crizotinib.
English: The data described below reflect exposure to XALKORI in 1669 patients with ALK-positive advanced NSCLC who participated in 2 randomised Phase 3 studies (Studies 1007 and 1014) and in 2 single-arm studies (Studies 1001 and 1005), and in 53 patients with ROS1-positive advanced NSCLC who participated in single-arm Study 1001, for a total of 1722 patients (see section 5.1).
Danish: De data, der er beskrevet herunder, afspejler XALKORI-eksponering hos 1.669 patienter med ALKpositiv fremskreden NSCLC, som deltog i 2 randomiserede fase 3-studier (studie 1007 og 1014), og i 2 enkeltarmsstudier (studie 1001 og 1005), samt hos 53 patienter med ROS1-positiv fremskreden NSCLC, der deltog i enkeltarmsstudie 1001, i alt 1.722 patienter (se pkt.
English: The most common adverse reactions (≥25%) in patients with either ALK-positive or ROS1-positive NSCLC were vision disorder, nausea, diarrhoea, vomiting, oedema, constipation, elevated transaminases, fatigue, decreased appetite, dizziness, and neuropathy.
Danish: De hyppigste bivirkninger (≥25%) hos patienter med enten ALK-positiv eller ROS1-positiv NSCLC var synsforstyrrelser, kvalme, diarré, opkastning, ødemer, obstipation, stigning i aminotransferase, træthed, appetitløshed, svimmelhed og neuropati.
English: Crizotinib resulted in overall global quality of life benefits with a significantly greater improvement from baseline observed in the crizotinib arm compared to the chemotherapy arm (Cycles 2 to 20; p-value <0.05).
Danish: Overordnet set resulterede crizotinib i fordele for den generelle livskvalitet, idet der sås signifikant større forbedring fra baseline i crizotinib-armen sammenlignet med kemoterapi-armen (cyklus 2 til 20, p < 0,05).
English: The most serious adverse reactions in 1722 patients with either ALK-positive or ROS1-positive advanced NSCLC were hepatotoxicity, ILD/pneumonitis, neutropenia, and QT interval prolongation (see section 4.4).
Danish: De alvorligste bivirkninger hos 1.722 patienter med enten ALK-positiv eller ROS1-positiv fremskreden NSCLC var hepatotoksicitet, ILD/pneumonitis, neutropeni og forlængelse af QTintervallet (se pkt.
English: In randomised Phase 3 Study 1014, increases to Grade 3 or 4 ALT or AST elevations were observed in 15% and 8% of patients receiving crizotinib versus 2% and 1% of patients receiving chemotherapy.
Danish: I det randomiserede fase 3-studie 1014 sås ALAT- eller ASATstigning til grad 3 eller 4 hos 15% og 8% af de patienter, der fik crizotinib, mod 2% og 1% af de patienter, der fik kemoterapi.
English: MARKETING AUTHORISATION NUMBER(S) XALKORI 200 mg hard capsules EU/1/12/793/001
Danish: XALKORI 200 mg hårde kapsler EU/1/12/793/001
English: Abbreviations: CI=confidence interval; HR=hazard ratio; IRR=independent radiology review; N/n=number of patients; NR=not reached; PFS=progression-free survival; OS=overall survival.
Danish: Forkortelser: CI = konfidensinterval; HR = risikorate (hazard ratio); IRR = uafhængig radiologisk gennemgang (Independent Radiology Review); N/n = antal patienter; NR = ikke nået (not reached); PFS = progressionsfri overlevelse (Progression-free Survival); OS = samlet overlevelse (Overall Survival).
English: N=765a
Danish: N=765
English: Monitoring of patients for renal function at baseline and during therapy with crizotinib is recommended, with particular attention to those who have risk factors or previous history of renal impairment (see section 4.8).
Danish: Det anbefales at overvåge nyrefunktionen ved baseline og under behandling med crizotinib, med særlig opmærksomhed rettet mod patienter, med kendte risikofaktorer eller med nedsat nyrefunktion i anamnesen (se pkt.
English: Optic atrophy and optic nerve disorder have been reported as potential causes of vision loss.
Danish: Der er rapporteret om optisk atrofi og synsnervelidelse som mulige årsager til synstab.
English: In vitro studies in human liver microsomes demonstrated that crizotinib is a time-dependent inhibitor of CYP2B6 and CYP3A (see section 4.5).
Danish: In vitro studier i humane lever-mikrosomer viser at crizotinib er en tidsafhængig hæmmer af CYP2B6 og CYP3A (se pkt.
English: • Do not use any pack that is damaged or shows signs of tampering.
Danish: • Brug ikke lægemidlet, hvis indhold og/eller pakning er skadet eller har været åbnet.
English: Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are metabolized predominantly by UGT1A1 (e.g., raltegravir, irinotecan) or UGT2B7 (e.g., morphine, naloxone).
Danish: Dermed kan crizotinib potentielt øge plasmakoncentrationen af samtidig administrerede lægemidler, som overvejende metaboliseres af UGT1A1 (fx raltegravir, irinotecan) eller UGT2B7 (morphin, naloxon).
English: Objective Response Rate [% (95% CI)] Time to Tumour Response [median (range)] weeks Duration of Responseb [median (95% CI)] months Progression-Free Survivalb [median (95% CI)] months OSb [median (95% CI)] months
Danish: Objektiv responsrate [% (95% CI)] Tid til respons [median (interval)] uger Responsvarighed b [median (95% CI)] måneder Progressionsfri overlevelse b [median (95% CI)]
English: There were no findings related to aqueous cell count and anterior chamber aqueous flare assessment.
Danish: Der var ingen fund i forbindelse med optælling af celler og flare i kammervæsken.
English: Of 154 and 1063 ALK-positive NSCLC patients in single arm studies 1001 and 1005, 22 (14%) and 173 (16%) were 65 years or older, respectively.
Danish: Af de 154 og 1.063 ALK-positive NSCLC-patienter i de 2 enkeltarmsstudier 1001 og 1005 var hhv. 22 (14%) og 173 (16%) 65 år eller ældre.
English: Crizotinib showed a significantly greater improvement from baseline compared to chemotherapy in alopecia (Cycles 2 to 15; p-value <0.05), cough (Cycles 2 to 20; p-value <0.0001), dyspnoea (Cycles 2 to 20; p-value <0.0001), haemoptysis (Cycles 2 to 20; p-value <0.05), pain in arm or shoulder (Cycles 2 to 20; p-value <0.0001), pain in chest (Cycles 2 to 20; p-value <0.0001), and pain in other parts (Cycles 2 to 20; p-value <0.05).
Danish: Crizotinib udviste signifikant større forbedring fra baseline sammenlignet med kemoterapi med hensyn til alopeci (cyklus 2 til 15, p < 0,05), hoste (cyklus 2 til 20, p < 0,0001), dyspnø (cyklus 2 til 20, p < 0,0001), hæmoptyse (cyklus 2 til 20, p < 0,05), smerter i arm eller skulder (cyklus 2 til 20, p < 0,0001), smerter i brystet (cyklus 2 til 20, p < 0,0001) og smerter i andre dele af kroppen (cyklus 2 til 20, p < 0,05).
English: Coadministration of crizotinib with strong CYP3A inhibitors is expected to increase crizotinib plasma concentrations.
Danish: Lægemidler, som kan øge plasmakoncentrationen af crizotinib Administration af crizotinib sammen med potente CYP3A-hæmmere forventes at øge plasmakoncentrationen af crizotinib.
English: CI: 2, 16) for docetaxel (p-value <0.0001 compared with crizotinib).
Danish: 16) for docetaxel (p < 0,0001 sammenlignet med crizotinib).
English: Complete blood counts including differential white blood cell counts should be monitored as clinically indicated, with more frequent repeat testing if Grade 3 or 4 abnormalities are observed, or if fever or infection occurs.
Danish: Fuldstændig blodtælling inklusive differentialtælling af hvide blodlegemer bør foretages, når det er klinisk påkrævet, med hyppigere gentestning ved sværhedsgrad 3- og 4 afvigende fund, eller i tilfælde af feber eller infektion.
English: The PFS benefit of crizotinib was consistent across subgroups of baseline patient characteristics such as age, gender, race, smoking class, time since diagnosis, ECOG performance status, and presence of brain metastases.
Danish: Fordelen ved crizotinib med hensyn til PFS var konsistent på tværs af undergrupper, baseret på baseline-patientkarakteristika som alder, køn, race, rygestatus, tid siden diagnosticering, ECOG-performancestatus og tilstedeværelse af hjernemetastaser.
English: The most frequent adverse reactions (≥3%, all-causality frequency) associated with dosing interruptions were neutropenia (11%), elevated transaminases (7%), vomiting (5%), and nausea (4%).
Danish: De hyppigste bivirkninger (≥3%, uanset kausalitet) i forbindelse med behandlingsafbrydelse var neutropeni (11%), aminotransferasestigning (7%), opkastning (5%) og kvalme (4%).
English: A total of 162 patients in the crizotinib arm and 151 patients in the chemotherapy arm had completed the EORTC QLQ-C30 and LC13 questionnaires at baseline and at least 1 postbaseline visit.
Danish: I alt udfyldte 162 patienter i crizotinib-armen og 151 patienter i kemoterapi-armen spørgeskemaerne EORTC QLQ-C30 og LC-13 ved baseline og ved mindst 1 besøg efter baseline.
English: Patients who develop symptomatic bradycardia should be managed as recommended in the Dose Modification and Warnings and Precautions sections (see sections 4.2, 4.4 and 4.5).
Danish: Patienter, der udvikler symptomatisk bradykardi, bør behandles efter anbefalingerne i afsnittene Dosisjustering og Advarsler og forsigtighedsregler (se pkt.
English: f. ORRs were 29% (95% CI: 21, 39) for pemetrexed (p-value <0.0001 compared with crizotinib) and 7% (95%
Danish: f. ORR var 29% (95% CI: 21, 39) for pemetrexed (p < 0,0001 sammenlignet med crizotinib) og 7% (95% CI: 2,
English: Significantly greater improvement in global QOL was observed in the crizotinib arm compared to the chemotherapy arm (overall difference in change from baseline scores 13.8; p-value <0.0001).
Danish: livskvalitet (QoL) i crizitonib-armen sammenlignet med kemoterapi-armen (samlet forskel i ændring fra baseline var 13,8; p <0,0001).
English: e. For patients treated with 250 mg once daily or whose dose was reduced to 250 mg once daily, discontinue during evaluation.
Danish: Patienter, som blev behandlet med 250 mg 1 gang dagligt, eller hvis dosis blev nedsat til 250 mg 1 gang dagligt, skal have behandlingen seponeret under evalueringen.
English: The PFS benefit of crizotinib was consistent across subgroups of baseline patient characteristics such as age, gender, race, smoking class, time since diagnosis, ECOG performance status, presence of brain metastases and prior EGFR TKI therapy.
Danish: Fordelen ved crizotinib med hensyn til PFS var konsistent på tværs af undergrupperne, baseret på patientkarakteristika ved baseline som alder, køn, race, rygestatus, forløbet tid siden diagnosticering, status for ECOG, tilstedeværelse af hjernemetastaser og tidligere behandling med EGFR tyrosinkinasehæmmer.