natgillin/translations-raw huggingface dataset:
Alle øvre grænser for 90% CI for LS middelændring af QTcF fra baseline på alle tidspunkter på dag 1 i cyklus 2 var &lt; 20 ms.
All upper limits of the 90% CI for the LS mean change from Baseline in QTcF at all Cycle 2 Day 1 time points were &lt; 20 msec.
Den centrale tendensanalyse indikerede, at alle øvre grænser for 90% CI for middelændringen (beregnet efter mindste kvadraters metode LS) i QTcF fra baseline ved alle målepunkter på dag 1 i cyklus 2 var &lt; 20 ms. En farmakokinetisk/farmakodynamisk analyse antyder en sammenhæng mellem crizotinibs plasmakoncentration og QTc.
The central tendency analysis indicated that all upper limits of the 90% CI for the LS mean change from Baseline in QTcF at all Cycle 2 Day 1 time points were &lt; 20 msec. A pharmacokinetic/pharmacodynamic analysis suggested a relationship between crizotinib plasma concentration and QTc.
Dosis blev reduceret, eller behandlingen seponeret permanent på grund af neutropeni hos henholdsvis 3% og &lt; 1% af patienterne.
Neutropenia was associated with dose reduction or permanent treatment discontinuation for 3% and &lt; 1% of patients, respectively.
Ifølge en uafhængig undersøgelseskomités (IRC) vurdering af patienter med ALK-positiv NSCLC (N=1.669) havde 20 (1,2%) af patienterne ILD/pneumonitis, herunder 10 ( &lt; 1%) med dødelig udgang.
According to an independent review committee (IRC) assessment of patients with ALK-positive NSCLC (N=1669), 20 (1.2%) patients had ILD/pneumonitis, including 10 ( &lt; 1%) patients with fatal cases.
Der var én ALK-positiv patient &gt; 85 år ud af 154 patienter i enkeltarmsstudiet 1001 (se også pkt.
There was one ALK-positive patient &gt; 85 years old out of 154 patients in single-arm Study 1001 (see also section 4.2 and 5.2).
Efter en enkeltdosis på 250 mg hos forsøgspersoner med svært nedsat nyrefunktion (CLcr &lt; 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 &lt; 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.
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 &lt; 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 &lt; 0.05).
Crizotinib udviste signifikant større forbedring fra baseline sammenlignet med kemoterapi med hensyn til alopeci (cyklus 2 til 15, p &lt; 0,05), hoste (cyklus 2 til 20, p &lt; 0,0001), dyspnø (cyklus 2 til 20, p &lt; 0,0001), hæmoptyse (cyklus 2 til 20, p &lt; 0,05), smerter i arm eller skulder (cyklus 2 til 20, p &lt; 0,0001), smerter i brystet (cyklus 2 til 20, p &lt; 0,0001) og smerter i andre dele af kroppen (cyklus 2 til 20, p &lt; 0,05).
Crizotinib showed a significantly greater improvement from baseline compared to chemotherapy in alopecia (Cycles 2 to 15; p-value &lt; 0.05), cough (Cycles 2 to 20; p-value &lt; 0.0001), dyspnoea (Cycles 2 to 20; p-value &lt; 0.0001), haemoptysis (Cycles 2 to 20; p-value &lt; 0.05), pain in arm or shoulder (Cycles 2 to 20; p-value &lt; 0.0001), pain in chest (Cycles 2 to 20; p-value &lt; 0.0001), and pain in other parts (Cycles 2 to 20; p-value &lt; 0.05).
16) for docetaxel (p &lt; 0,0001 sammenlignet med crizotinib).
CI: 2, 16) for docetaxel (p-value &lt; 0.0001 compared with crizotinib).
f. ORR var 29% (95% CI: 21, 39) for pemetrexed (p &lt; 0,0001 sammenlignet med crizotinib) og 7% (95% CI: 2,
f. ORRs were 29% (95% CI: 21, 39) for pemetrexed (p-value &lt; 0.0001 compared with crizotinib) and 7% (95%
livskvalitet (QoL) i crizitonib-armen sammenlignet med kemoterapi-armen (samlet forskel i ændring fra baseline var 13,8; p &lt; 0,0001).
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 &lt; 0.0001).
Crizotinib gav symptomatiske fordele gennem en signifikant forlængelse af tiden indtil forværring (median 4,5 måneder mod 1,4 måneder) hos patienter, som rapporterede symptomer på smerter i brystet, dyspnø eller hoste sammenlignet med kemoterapi (HR 0,50, 95% CI: 0,37; 0,66, Hochbergjusteret log-rank 2-sidet p &lt; 0,0001).
Crizotinib resulted in symptoms benefit by significantly prolonging time to deterioration (median 4.5 months versus 1.4 months) in patients who reported symptoms of pain in chest, dyspnoea, or cough, compared to chemotherapy (HR 0.50; 95% CI: 0.37, 0.66; Hochberg adjusted log-rank p &lt; 0.0001).
I det randomiserede fase 3-studie 1007 sås grad 3 eller 4 ALAT- eller ASAT-stigning hos 18% og 9% af de patienter, der fik crizotinib, og 5% og &lt; 1% af de patienter, der fik kemoterapi.
In randomised Phase 3 Study 1007, increases to Grade 3 or 4 ALT or AST elevations were observed in 18% and 9% of patients receiving crizotinib and 5% and &lt; 1% of patients receiving chemotherapy.
Crizotinib resulterede i signifikant mindre forværring fra baseline i perifer neuropati (cyklus 6 til 20, p &lt; 0,05), dysfagi (cyklus 5 til 11, p &lt; 0,05) og øm mund (cyklus 2 til 20, pi &lt; 0,05) sammenlignet med kemoterapi.
Crizotinib resulted in a significantly lower deterioration from baseline in peripheral neuropathy (Cycles 6 to 20; p-value &lt; 0.05), dysphagia (Cycles 5 to 11; p-value &lt; 0.05) and sore mouth (Cycle 2 to 20; p-value &lt; 0.05) compared to chemotherapy.
Til patienter med moderat nedsat leverfunktion (enhver ASAT og total bilirubin &gt; 1,5 × ULN og  3 × ULN) anbefales en startdosis på 200 mg to gange dagligt.
The starting crizotinib dose for patients with moderate hepatic impairment (any AST and total bilirubin &gt; 1.5 × ULN and 3 × ULN) is recommended to be 200 mg twice daily.
Nyresvigt ( &lt; 1%)
Acute renal failure ( &lt; 1%) Renal failure
rapporterede synsforstyrrelser, som opstod med en frekvens på 4 til 7 dage hver uge, varede i op til 1 minut og havde let eller ingen indvirkning (score på 0 til 3 af en maksimal score på 10) på de daglige aktiviteter i henhold til de indhentede oplysninger fra spørgeskemaet VSAQ-ALK.
The majority of patients on the crizotinib arm in randomised Phase 3 Studies 1007 and 1014 ( &gt; 50%) reported visual disturbances; which occurred at a frequency of 4 to 7 days each week, lasted up to 1 minute, and had mild or no impact (scores 0 to 3 out of a maximum score of 10) on daily activities as captured by the VSAQ-ALK questionnaire.
Til patienter med svært nedsat leverfunktion (enhver ASAT og total bilirubin &gt; 3 × ULN) anbefales en startdosis på 250 mg en gang dagligt (se pkt.
The starting crizotinib dose for patients with severe hepatic impairment (any AST and total bilirubin &gt; 3 × ULN) is recommended to be 250 mg once daily (see section 5.2).
Elleve (21%) patienter havde en stigning i baseline-QTcF ≥30 på &lt; 60 ms og en patient (2%) havde en stigning fra baseline-QTcF på ≥60 ms. Ingen patienter havde maksimum QTcF ≥480 ms.
Eleven (21%) patients had an increase from Baseline in QTcF value ≥30 to &lt; 60 msec and 1 (2%) patient had an increase from Baseline in QTcF value of ≥60 msec. No patients had a maximum QTcF ≥480 msec.
Mediantiden for PFS var 6,9 måneder (95% CI: 6,6-8,3) for pemetrexed/cisplatin (HR = 0,49; p &lt; 0,0001 for crizotinib sammenlignet med pemetrexed/cisplatin) og 7,0 måneder (95% CI: 5,9-8,3) for pemetrexed/carboplatin (HR = 0,45; p &lt; 0,0001 for crizotinib sammenlignet med pemetrexed/carboplatin).
a. Median PFS times were 6.9 months (95% CI: 6.6, 8.3) for pemetrexed/cisplatin (HR=0.49; p-value &lt; 0.0001 for crizotinib compared with pemetrexed/cisplatin) and 7.0 months (95% CI: 5.9, 8.3) for pemetrexed/carboplatin
I alle studier hos patienter med enten ALK-positiv eller ROS1-positiv NSCLC (N=1.722) havde 50 (3%) af de patienter, der blev behandlet med crizotinib, ILD (uanset kausalitet) af en eller anden grad, herunder 18 (1%) patienter med grad 3 eller 4 og 8 ( &lt; 1%) tilfælde med dødelig udgang.
Across studies in patients with either ALK-positive or ROS1-positive NSCLC (N=1722), 50 (3%) patients treated with crizotinib had any grade all-causality ILD, including 18 (1%) patients with Grade 3 or 4, and 8 ( &lt; 1%) patients with fatal cases.
* PFS, objektiv responsrate og responsvarighed er baseret på data ved cutoff-dato 30. marts 2012, OS er baseret på data ved cutoff-dato 31. august 2015. a. Mediantiden for PFS var 4,2 måneder (95% CI: 2,8, 5,7) for pemetrexed (HR = 0,59, p = 0,0004 for crizotinib sammenlignet med pemetrexed) og 2,6 måneder (95% CI: 1,6, 4,0) for docetaxel (HR = 0,30, p &lt; 0,0001 for crizotinib sammenlignet med docetaxel).
OS is based on the data cutoff date of 31 August 2015. a. The median PFS times were 4.2 months (95% CI: 2.8, 5.7) for pemetrexed (HR=0.59; p-value=0.0004 for crizotinib compared with pemetrexed) and 2.6 months (95% CI: 1.6, 4.0) for docetaxel
5.2) med blindede, manuelle ekg-målinger havde 11 (21%) patienter en stigning i baseline QTcF på ≥30 til &lt; 60 ms og en patient (2%) havde en stigning i baseline QTcF på ≥60 ms. Ingen patienter havde maksimum-QTcF ≥480 ms.
In a single arm ECG substudy (see section 5.2) using blinded manual ECG measurements 11 (21%) patients had an increase from Baseline in QTcF value ≥30 to &lt; 60 msec and 1 (2%) patient had an increase from Baseline in QTcF value of ≥60 msec. No patients had a maximum QTcF ≥480 msec.
ORR var 47% (95% CI: 37-58) for pemetrexed/cisplatin (p &lt; 0,0001 sammenlignet med crizotinib) og 44% (95% CI: 32-55) for pemetrexed/carboplatin (p &lt; 0,0001 sammenlignet med crizotinib).
e. ORRs were 47% (95% CI: 37, 58) for pemetrexed/cisplatin (p-value &lt; 0.0001 compared with crizotinib) and
Den 11. oktober 2017 meddelte Merck Sharp &amp; Dohme officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden tilbagetrækker sin ansøgning om udvidelse af brugen af Keytruda til behandling af ikke-småcellet lungekræft (NSCLC) til også at omfatte metastatisk ikkepladecelle-NSCLC i kombination med kemoterapi.
On 11 October 2017, Merck Sharp &amp; Dohme officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend the use of Keytruda in nonsmall cell lung cancer (NSCLC) to include metastatic non-squamous NSCLC in combination with chemotherapy.
Denne indlægsseddel blev senest ændret &lt; dato for Kommissionens afgørelse &gt;
This leaflet was last revised in &lt; date of Commission Decision &gt;
Bivirkningernes hyppighed defineres som følger: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000), ikke kendte (kan ikke estimeres ud fra forhåndenværende data).
The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
I studie 1 havde kun 4 % af patienterne i Omidria-gruppen en pupildiameter &lt; 6 mm på tidspunktet for kortical oprensning sammenlignet med 23 % af patienterne i placebogruppen, og 3 % af patienterne i Omidria-gruppen sammenlignet med 28 % af patienterne i placebogruppen havde en pupilkonstriktion ≥ 2,5 mm (P &lt; 0,0001 i begge tilfælde, khi i anden-test).
In Study 1, only 4% of patients in the Omidria group compared to 23% of patients in the placebo group had a pupil diameter &lt; 6 mm at the time of cortical clean-up, and 3% of patients in the Omidria group compared to 28% of patients in the placebo group had a pupil constriction ≥2.5 mm (P &lt; 0.0001 in both instances, Chi-Square test).
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I studie 2 havde kun 4 % af patienterne i Omidria-gruppen en pupildiameter &lt; 6 mm ved kortical oprensning sammenlignet med 23 % af patienterne i placebogruppen, og 1 % af patienterne i Omidria-gruppen sammenlignet med 27 % af patienterne i placebogruppen havde en
In Study 2, only 4% of patients in the Omidria group compared to 23% of patients in the placebo group had a pupil diameter &lt; 6 mm at cortical clean-up, and 1% of patients in the Omidria group compared to 27% of patients in the placebo group had a pupil constriction ≥ 2.5 mm (P &lt; 0.0001, Chi-Square test).
I studie 1 var den CMHvægtede middelforskel (Omidria - placebo) i middelarealet under kurven (AUC) 0,58 mm [95 % konfidensinterval: 0,48, 0,68] (P &lt; 0,0001).
In Study 1, the CMH weighted mean difference (Omidria - placebo) in the mean area-under-the curve (AUC) was 0.58 mm [95% confidence interval: 0.48, 0.68] (P &lt; 0.0001).
I studie 2 var den CMH-vægtede middelforskel (Omidria - placebo) i middel-AUC -4,58 mm [95 % konfidensinterval: -6,92, -2,24] (P &lt; 0,001).
In Study 2, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was -4.58 mm [95% confidence interval: -6.92, -2.24] (P &lt; 0.001).
I studie 1 var den CMH-vægtede middelforskel (Omidriaplacebo) i middel-AUC -5,20 mm [95 % konfidensinterval: -7,31, -3,09] (P &lt; 0,001).
In Study 1, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was -5.20 mm [95% confidence interval: -7.31, -3.09] (P &lt; 0.001).
I studie 2 var den CMH-vægtede middelforskel (Omidriaplacebo) i middel-AUC 0,59 mm [95 % konfidensinterval: 0,49, 0,69] (P &lt; 0,0001).
In Study 2, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was 0.59 mm [95% confidence interval: 0.49, 0.69] (P &lt; 0.0001).
AUC-ændring fra baseline i pupildiameter (mm) under indgrebet (co-primært endepunkt) [MiddelSD]
AUC change from baseline in pupil diameter (mm) during surgery (Co-primary endpoint) [MeanSD)] Diameter &lt; 6 mm at any time Diameter &lt; 6 mm at cortical clean-up ≥ 2.5 mm pupillary constriction
Hyppigheden af bivirkninger er defineret som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1 000 til &lt; 1/100), sjælden (≥ 1/10 000 til &lt; 1/1 000), meget sjælden ( &lt; 1/10 000), ikke kendt (kan ikke beregnes af forhåndenværende data).
Frequency of the adverse reactions is defined as: very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100), rare (≥ 1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
For alle deltagernes tre månedlige vurderinger var der signifikant forskel mellem Senstend og placebo (p &lt; 0,0001).
For all of the three monthly assessments completed by the subjects, there was a significant difference between Senstend and placebo (p &lt; 0.0001).
66,2 % af de deltagere, der blev behandlet med Senstend, og 18,8 % af placebogruppen opnåede en gennemsnitlig IELT på over 2 minutter.
66.2% of Senstend-treated subjects and 18.8% of placebo-treated subjects achieved a mean IELT &gt; 2 minutes.
85,2 % af personerne i gruppen på Senstend opnåede en gennemsnitlig IELT på over 1 minut i løbet af 3 måneders behandling med Senstend, mens 46,4 % af placebogruppen havde en gennemsnitlig IELT på under 1 minut.
85.2% of subjects in the Senstend group achieved a mean IELT of &gt; 1 minute over the course of 3 months of treatment with it, whereas 46.4% of the placebo subjects had a mean IELT of &gt; 1 minute.
Infusionshastigheden mÃ¥ ikke Ã¸ges.
Do not increase the infusion rate.
Der sås ingen signifikant forskel i obinutuzumabs farmakokinetik blandt patienter &lt; 65 år (n=375), patienter mellem 65 og 75 år (n=265) og patienter &gt; 75 år (n=171).
No significant difference was observed in the pharmacokinetics of obinutuzumab among patients &lt; 65 years (n=375), patients between 65-75 years (n=265) and patients &gt; 75 years (n=171).
Sent indsættende neutropeni (28 dage efter endt behandling) eller forlænget neutropeni (varende mere end 28 dage efter behandlingen er gennemført/afbrudt)kan også forekomme.
Late onset neutropenia (occurring &gt; 28 days after the end of treatment) or prolonged neutropenia (lasting more than 28 days after treatment has been completed/stopped) may occur.
Disse patienter oplevede flere alvorlige bivirkninger og bivirkninger medførende død end patienter &lt; 75 år.
These patients experienced more serious adverse events and adverse events leading to death than those patients &lt; 75 years of age.
Median-CrCl var 62 ml/min, og 66% af alle patienterne havde en CrCl &lt; 70 ml/min.
The median estimated CrCl was 62 mL/min and 66% of all patients had a CrCl &lt; 70 mL/min.
Hyppigheder defineres som meget almindelig (≥1/10), almindelig (≥1/100 til &lt; 1/10), ikke almindelig (≥1/1000 til &lt; 1/100), sjælden (≥1/10.000 til &lt; 1/1000) og meget sjælden ( &lt; 1/10.000).
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000
De demografiske data og baseline-karakteristika af patientpopulationen var velafbalancerede mellem behandlingsarmene; median alder var 59 år, 81 % var kaukasere, 53 % var kvinder, 79% havde en FLIPI score på ≥ 2 og 7 % havde stadie II (bulky), 35 % havde stadie III og 57 % havde stadie IV sygdom, 44 % havde bulky sygdom ( &gt; 7 cm), 34% havde mindst et B-symptom ved baseline og 97% havde en ECOG performancestatus på 0-1 ved baseline.
The demographic data and baseline characteristics of the patient population were well balanced between the treatment arms; median age was 59 years, 81% were Caucasian, 53% were female, 79% had a FLIPI score of ≥ 2 and 7% had Stage II (bulky), 35% had Stage III and 57% had Stage IV disease, 44% had bulky disease ( &gt; 7 cm), 34% had at least one B-symptom at baseline and 97% had an ECOG performance status of 0-1 at baseline.
Infusionsrelaterede reaktioner er meget almindelige under den fÃ¸rste infusion af Gazyvaro og patienter, der oplever infusionsrelaterede symptomer bÃ¸r frarÃ¥des at fÃ¸re motorkÃ¸retÃ¸j eller betjene maskiner, indtil symptomerne er aftaget.
IRRs are very common during the first infusion of Gazyvaro, and patients experiencing infusion related symptoms should be advised not to drive or use machines until symptoms abate.
Infusioner med Gazyvaro mÃ¥ ikke gives som intravenÃ¸s stÃ¸d- eller bolusdosis.
Gazyvaro infusions should not be administered as an intravenous push or bolus.
I det pivotale kliniske studie, BO21004/CLL11, blev 91% (40 ud af 44) af de evaluérbare patienter behandlet med Gazyvaro B-celle-depleterede (defineret som CD19+ B-celletal &lt; 0,07x 109/l) i slutningen af behandlingsperioden og forblev depleterede igennem de første 6 måneder af opfølgningsperioden.
In the pivotal clinical study BO21004/CLL11, 91% (40 out of 44) of evaluable patients treated with Gazyvaro were B-cell depleted (defined as CD19+ B-cell counts &lt; 0.07 x 109/L) at the end of treatment period and remained depleted during the first 6 months of follow up.
Patienter med grad 3 infusionsrelateret reaktion under forudgående infusion ELLER patienter med lymfocyttal &gt; 25 x 109/l inden næste behandling
Patients with a Grade 3 IRR with the previous infusion OR Patients with lymphocyte counts &gt; 25 x 109/L prior to next treatment
Patienterne skulle inden inklusion have verificeret CD20+ CLL samt opfylde én eller begge af følgende mål for andre samtidige sygdomme: en co-morbiditetsscore (CIRS) på mere end 6 eller nedsat nyrefunktion svarende til CrCl &lt; 70 ml/min.
Prior to enrolment, patients had to have documented CD20+ CLL, and one or both of the following measures of coexisting medical conditions: comorbidity score (CIRS) of greater than 6 or reduced renal function as measured by CrCl &lt; 70 mL/min.
42% af patienterne havde både en CrCl &lt; 70 ml/min og en co-morbiditetsscore over 6.
Forty-two percent of patients enrolled had both a CrCl &lt; 70 mL/min and a comorbidity score of &gt; 6.
Infusionshastigheden kan Ã¸ges forudsat patienten kan tolerere dette For hÃ¥ndtering af infusionsrelateret reaktion, der opstÃ¥r under infusionen, se "HÃ¥ndtering af infusionsrelaterede reaktioner".
The infusion rate may be escalated provided that the patient can tolerate it. For management IRRs that occur during the infusion, refer to “Management of IRRs”.
Infusionsrelaterede reaktioner kan vÃ¦re svÃ¦re at skelne klinisk fra immunglobulin E (IgE)-medierede allergiske reaktioner (fx anafylaksi).
IRRs may be clinically indistinguishable from immunoglobulin E (IgE) mediated allergic reactions (e.g. anaphylaxis).
Incidensen af infektion var 38% i Gazyvaro plus chlorambucil-armen og 37% i rituximab plus chlorambucil-armen (bivirkninger af grad 3-5 indberettet for henholdsvis 12% og 14%, og dødelige bivirkninger for &lt; 1% i begge behandlingsarme).
The incidence of infection was 38% in the Gazyvaro plus chlorambucil arm and 37% in the rituximab plus chlorambucil arm (with Grade 3-5 events reported in 12% and 14%, respectively and fatal events reported in &lt; 1% in both treatment arms).
I det pivotale BO21004/CLL11-studie havde 27% (90 ud af 336) af patienterne behandlet med Gazyvaro plus chlorambucil moderat nedsat nyrefunktion (CrCl &lt; 50 ml/min).
In the pivotal BO21004/CLL11 study, 27% (90 out of 336) of patients treated with Gazyvaro plus chlorambucil had moderate renal impairment (CrCl &lt; 50 mL/min).
Patienter med CrCl &lt; 30 ml/min blev ekskluderet fra studiet (se pkt.
Patients with a CrCl &lt; 30 mL/min were excluded from the study (see section 5.1).
Patienter med CrCl &lt; 40 ml/min blev ekskluderet fra studierne (se pkt.
Patients with a CrCl &lt; 40 mL/min were excluded from the studies (see section 5.1).
Patienterne var stratificeret udfra region, subgruppe af indolent non-Hodgkin lymfom (follikulært versus ikke-follikulært), rituximab-refraktær type (hvorvidt patienten var refraktær over for tidligere rituximab monoterapi eller rituximab i kombination med kemoterapi) samt antallet af tidligere behandlinger (≤ 2 versus &gt; 2).
Patients were stratified according to region, iNHL subtype (follicular versus non-follicular), rituximab-refractory type (whether refractory to prior rituximab monotherapy or rituximab in combination with chemotherapy)
Patienter med nedsat nyrefunktion (CrCl &lt; 50 ml/min) har højere risiko for neutropeni (se pkt.
Patients with renal impairment (CrCl &lt; 50 mL/min) are more at risk of neutropenia (see section 4.8).
Patienter med nedsat leverfunktion (grad 3 ved NCI's definition (ASAT/ALAT &gt; 5 x øvre grænseværdi i &gt; 2 uger; bilirubin &gt; 3 x øvre grænseværdi) og nedsat nyrefunktion (CrCl &lt; 30 ml/min) kunne ikke deltage i studiet.
Patients with inadequate liver function (National Cancer Institute - Common Terminology Criteria for Adverse Events Grade 3 liver function tests (AST, ALT &gt; 5 x ULN for &gt; 2 weeks; bilirubin &gt; 3 x ULN) and renal function (CrCl &lt; 30 mL/min) were excluded.
Sikkerhed og virkning af Gazyvaro hos patienter med alvorlig nedsat nyrefunktion (CrCl &lt; 30 ml/min) er ikke klarlagt (se pkt.
The safety and efficacy of Gazyvaro has not been established in patients with severe renal impairment (CrCl &lt; 30 mL/min) (see sections 4.8 and 5.2).
Patienter der vurderes at være i risiko for tumorlysesyndrom (fx patienter med høj tumorbyrde og/eller højt antal cirkulerende lymfocytter [ &gt; 25 x 109/l]) og/eller nedsat nyrefunktion (CrCl &lt; 70 ml/min) bør have profylakse.
Patients who are considered to be at risk of TLS (e.g. patients with a high tumour burden and/or a high circulating lymphocyte count [ &gt; 25 x 109/L] and/or renal impairment [CrCl &lt; 70 mL/min]) should receive prophylaxis.
Patienter med nedsat nyrefunktion (CrCl &lt; 50 ml/min) har højere risiko for trombocytopeni (se pkt.
Patients with renal impairment (CrCl &lt; 50 mL/min) are more at risk of thrombocytopenia (see section 4.8).