natgillin/translations-raw huggingface dataset:
Administration af en enkelt dosis på 250 mg crizotinib efter behandling med 40 mg esomeprazol en gang dagligt i 5 dage resulterede i et fald på ca. 10% i den samlede crizotinib-eksponering (AUCinf) og ingen ændring i den maksimale eksponering (Cmax).
Administration of a single 250 mg crizotinib dose following treatment with esomeprazole 40 mg once daily for 5 days resulted in an approximately 10% decrease in crizotinib total exposure (AUCinf) and no change in peak exposure (Cmax); the extent of the change in total exposure was not clinically meaningful.
Undgå så vidt det er muligt at bruge crizotinib i kombination med andre lægemidler, der kan give bradykardi (fx beta-blokkere, non-dihydropyridin calciumantagonister såsom verapamil og diltiazem, clonidin, digoxin), på grund af den øgede risiko for symptomatisk bradykardi.
Avoid using crizotinib in combination with other bradycardic agents (e.g., beta-blockers, non-dihydropyridine calcium channel blockers such as verapamil and diltiazem, clonidine, digoxin) to the extent possible, due to the increased risk of symptomatic bradycardia.
• Den anbefalede dosis er 1 kapsel på 250 mg, som synkes 2 gange dagligt (i alt 500 mg).
• The recommended dose is one capsule of 250 mg taken orally twice daily (total amount
I den samlede analysepopulation indgik 347 patienter med ALK-positiv fremskreden NSCLC, som var diagnosticeret med FISH inden randomiseringen.
The full analysis population included 347 patients with ALK-positive advanced NSCLC as identified by FISH prior to randomisation.
I alt 934 patienter med ALK-positiv fremskreden NSCLC var blevet behandlet med crizotinib i studie 1005 på det tidspunkt, hvor data blev opgjort for PFS- og ORR-analysen.
A total of 934 patients with ALK-positive advanced NSCLC were treated with crizotinib in Study 1005 at the time of data cutoff for PFS and ORR analysis.
Medicinen nævnt herunder kan især øge risikoen for at få bivirkninger af XALKORI:
In particular, the following medicines may increase the risk of side effects with XALKORI:
In vitro studier i humane hepatocytter antyder, at kliniske lægemiddelinteraktioner som følge af crizotinib-medieret induktion af metaboliseringen af lægemidler, som er substrater for CYP1A2, ikke er sandsynlige.
In vitro studies in human hepatocytes indicated that clinical drug-drug interactions are unlikely to occur as a result of crizotinib-mediated induction of the metabolism of medicinal products that are substrates for CYP1A2.
Fund i reproduktionsvejene hos hunrotter er enkeltcellenekrose i ovariefolikler ved doser på 500 mg/kg/dag for 3 dage.
Findings observed in the female reproductive tract included single-cell necrosis of ovarian follicles of a rat given 500 mg/kg/day for 3 days.
h) Hjertesvigt (hjertesvigt, kronisk venstresidig hjerteinsufficiens, nedsat uddrivningsfraktion, venstre ventrikelsvigt, lungeødem).
h. Cardiac failure (Cardiac failure, Cardiac failure congestive, Ejection fraction decreased, Left ventricular failure, Pulmonary oedema).
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.
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.
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.
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.
• Dabigatran, får blodet til at størkne langsommere.
• Dabigatran, anticoagulant used to slow down clotting of the blood.
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.
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.
I kliniske studier sås bradykardi af enhver årsag hos 13% af de patienter, der blev behandlet med crizotinib.
All-causality bradycardia was reported in clinical studies in 13% of patients treated with crizotinib.
j) Abdominalsmerter (abdominalt ubehag, abdominalsmerter, smerter i nedre abdomen, smerter i øvre abdomen,
j. Abdominal pain (Abdominal discomfort, Abdominal pain, Abdominal pain lower, Abdominal pain upper, Abdominal tenderness).
Nyrefunktionens indvirkning på de observerede trough-koncentrationer af crizotinib (Ctrough, ss) ved steady state blev vurderet ud fra baseline CLcr.
The effect of renal function as measured by baseline CLcr on observed crizotinib steady-state trough concentrations (Ctrough, ss) was evaluated.
PVC-folieblister indeholdende 10 hårde kapsler.
PVC-foil blisters containing 10 hard capsules.
Kvalme (57%), diarré (54%), opkastning (51%) og obstipation (43%) var de hyppigst indberettede bivirkninger fra mave-tarm-kanalen (uanset kausalitet).
Nausea (57%), diarrhoea (54%), vomiting (51%), and constipation (43%) were the most commonly reported all-causality gastrointestinal events.
Administration af crizotinib sammen med potente CYP3A4-hæmmere eller sammen med potente eller moderate3A4 induktorer bør undgås (se pkt.
The concomitant use of crizotinib with strong CYP3A4 inhibitors or with strong and moderate CYP3A4 inducers should be avoided (see section 4.5).
Af de 172 ALKpositive patienter, der blev behandlet med crizotinib i det randomiserede fase 3-studie 1007, var 27 (16%) 65 år eller ældre.
Of 172 ALK-positive patients treated with crizotinib in randomised Phase 3 Study 1007, 27 (16%) were 65 years or older.
Andre mulige årsager til ILD/pneumonitis skal udelukkes (se pkt.
Other potential causes of ILD/pneumonitis should be excluded (see sections 4.2 and 4.4).
Kontakt lægen, hvis du har spørgsmål om, hvordan XALKORI virker, eller hvorfor du har fået denne medicin.
If you have any questions about how XALKORI works or why this medicine has been prescribed for you, ask your doctor.
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).
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).
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.
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.
Pfizer Europe MA EEIG (som MAH-logo)
NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MAH logo)
Udslæt (13%)
Rash (13%)
Crizotinib er en hæmmer af organisk kationtransporter 1 og 2 (OCT1 og OCT2) in vitro.
Crizotinib is an inhibitor of OCT1 and OCT2 in vitro.
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).
Abbreviations: CI=confidence interval; HR=hazard ratio; IRR=independent radiology review; N/n=number of patients; PFS=progression-free survival; OS=overall survival.
For ALK-positive NSCLC-patienter i studie 1001 (N=154) og 1005 (N=1.063) var den mediane behandlingsvarighed hhv. 57 og 45 uger.
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.
Du skal undgå ovenstående medicin under behandlingen med XALKORI.
These medicines should be avoided during your treatment with XALKORI.
CTCAE c-grad
CTCAEa Grade
Progressionsfri overlevelse (baseret på IRR) Antal med hændelse, n (%) Median PFS i måneder (95% CI)
Progression-Free Survival (Based on IRR) Number with event, n (%) Median PFS in months (95% CI)
Neuropati af enhver årsag, som defineret i skema 3, blev set hos 435 (25%) af de 1.722 patienter, der blev behandlet med crizotinib.
All-causality neuropathy, as defined in Table 3, was experienced by 435 (25%) out of 1722 patients treated with crizotinib.
Der er ingen data fra kliniske studier for anvendelse af crizotinib under graviditet.
There are no data in pregnant women using crizotinib.
Effektdata fra patienter med ROS1-positiv fremskreden NSCLC i studie 1001 er anført i Skema 7.
Efficacy data from ROS1-positive advanced NSCLC patients from Study 1001 are provided in Table 7.
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.
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.
• Pilocarpin, til behandling af forhøjet tryk i øjet (grøn stær - en alvorlig øjensygdom).
• Pilocarpine, used to treat glaucoma (a severe eye disease).
Der er få tilgængelige data fra patienter med ALK-positiv og ROS1-positiv NSCLC med nonadenokarcinom-histologi, herunder planocellulært karcinom (SCC) (se pkt.
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).
HDPE beholder med polypropylenlåg indeholdende 60 hårde kapsler.
HDPE bottles with a polypropylene closure containing 60 hard capsules.
Af de 53 ROS1-positive NSCLC-patienter i enkeltarmsstudie 1001 var 15 (28%) 65 år eller ældre.
Of the 53 ROS1-positive NSCLC patients in single arm Study 1001, 15 (28%) were 65 years or older.
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.
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.
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.
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.
Antal dødsfald, n (%) Samlet overlevelse c [median (95% CI)] måneder
Number of deaths, n (%) Overall Survivalc [median (95% CI)] months
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.
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.
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.
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.
e. Estimeret ved Kaplan-Meier-metoden.
e. Estimated using the Kaplan-Meier method.
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.
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.
Optisk atrofi og synsnervelidelse er blevet rapporteret som mulige årsager til synstab (se pkt.
Optic atrophy and optic nerve disorder have been reported as potential causes of vision loss (see section 4.4).
ALK-positiv fremskreden NSCLC effektdata fra studie 1001 og 1005 Virkningsparameter
Table 6: ALK-positive advanced NSCLC efficacy results from Studies 1001 and 1005 Efficacy Parameter
Påvirkning af nervesystemet
Nervous system effects
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).
Patients randomised to chemotherapy could cross over to receive crizotinib upon RECIST-defined disease progression confirmed by independent radiology review (IRR).
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).
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).
Den terminale plasmahalveringstid for en enkeltdosis crizotinib er 42 timer.
Following single doses of crizotinib, the apparent plasma terminal half-life of crizotinib was 42 hours in patients.
• Irinotecan, til behandling af kræft i tyktarm og endetarm.
• Irinotecan, a chemotherapy drug used to treat cancer of the colon and rectum.
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.
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).
Kapselskal indeholder: gelatine, titaniumdioxid (E171) og rød jernoxid (E172).
Capsule shell: gelatin, titanium dioxide (E171), and red iron oxide (E172).
• Unormale blodprøveresultater for leverfunktionen.
• Abnormalities in liver blood tests.
Der er set lægemiddelinduceret levertoksicitet med dødelig udgang hos 0,1% ud af 1.722 patienter i alle kliniske studier under behandling med crizotinib.
Drug-induced hepatotoxicity with fatal outcome occurred in 0.1% of 1722 patients treated with crizotinib across clinical trials.
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.
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).
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.
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.
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).
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).
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.
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).
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.
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.
XALKORI 200 mg hårde kapsler EU/1/12/793/001
MARKETING AUTHORISATION NUMBER(S) XALKORI 200 mg hard capsules EU/1/12/793/001
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).
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.
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.
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).
Der er rapporteret om optisk atrofi og synsnervelidelse som mulige årsager til synstab.
Optic atrophy and optic nerve disorder have been reported as potential causes of vision loss.
In vitro studier i humane lever-mikrosomer viser at crizotinib er en tidsafhængig hæmmer af CYP2B6 og CYP3A (se pkt.
In vitro studies in human liver microsomes demonstrated that crizotinib is a time-dependent inhibitor of CYP2B6 and CYP3A (see section 4.5).
• Brug ikke lægemidlet, hvis indhold og/eller pakning er skadet eller har været åbnet.
• Do not use any pack that is damaged or shows signs of tampering.
Dermed kan crizotinib potentielt øge plasmakoncentrationen af samtidig administrerede lægemidler, som overvejende metaboliseres af UGT1A1 (fx raltegravir, irinotecan) eller UGT2B7 (morphin, naloxon).
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).
Objektiv responsrate [% (95% CI)] Tid til respons [median (interval)] uger Responsvarighed b [median (95% CI)] måneder Progressionsfri overlevelse b [median (95% CI)]
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
Der var ingen fund i forbindelse med optælling af celler og flare i kammervæsken.
There were no findings related to aqueous cell count and anterior chamber aqueous flare assessment.
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.
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.
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).
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).
Lægemidler, som kan øge plasmakoncentrationen af crizotinib Administration af crizotinib sammen med potente CYP3A-hæmmere forventes at øge plasmakoncentrationen af crizotinib.
Coadministration of crizotinib with strong CYP3A inhibitors is expected to increase crizotinib plasma concentrations.
16) for docetaxel (p < 0,0001 sammenlignet med crizotinib).
CI: 2, 16) for docetaxel (p-value <0.0001 compared with crizotinib).
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.
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.
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.
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.
De hyppigste bivirkninger (≥3%, uanset kausalitet) i forbindelse med behandlingsafbrydelse var neutropeni (11%), aminotransferasestigning (7%), opkastning (5%) og kvalme (4%).
The most frequent adverse reactions (≥3%, all-causality frequency) associated with dosing interruptions were neutropenia (11%), elevated transaminases (7%), vomiting (5%), and nausea (4%).
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.
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.