natgillin/translations-raw huggingface dataset:
MicardisPlus må ikke anvendes til patienter med svært nedsat nyrefunktion (kreatinin-clearance &lt; 30 ml/min).
MicardisPlus must not be used in patients with severe renal impairment (creatinine clearance &lt; 30 ml/min) (see section 4.3).
Infektioner og parasitÃ¦re sygdomme Ikke kendt:
Infections and infestations Not known:
Infektioner og parasitÃ¦re sygdomme SjÃ¦lden: Immunsystemet SjÃ¦lden:
Infections and infestations Rare:
Emtricitabins binding in vitro til humane plasmaproteiner var &lt; 4% og uafhængig af koncentrationsområdet på 0,02 til 200 µg/ml.
In vitro binding of emtricitabine to human plasma proteins was &lt; 4% and independent of concentration over the range of 0.02 to 200 μg/ml.
Emtricitabin/tenofovirdisoproxil bør kun anvendes hos personer med kreatininclearance (CrCl) &lt; 80 ml/min, hvis de potentielle fordele anses for at opveje de potentielle risici.
Emtricitabine/tenofovir disoproxil should only be used in individuals with creatinine clearance (CrCl) &lt; 80 ml/min if the potential benefits are considered to outweigh the potential risks.
Forskellen i andelen af patienter, der fortsat havde &lt; 400 kopier/ml i uge 48, skyldtes hovedsageligt, at flere seponerede behandlingen i gruppen, der fik tenofovirdisoproxil.
The difference in the proportion of patients who maintained &lt; 400 copies/ml at week 48 was mainly influenced by the higher number of discontinuations in the tenofovir disoproxil treatment group.
De primære virkningsendepunkter i dette studie var at opnå og vedligeholde bekræftede HIV 1-RNA-koncentrationer &lt; 400 kopier/ml i 48 uger.
The primary efficacy endpoint for this study was the achievement and maintenance of confirmed HIV-1 RNA concentrations &lt; 400 copies/ml over 48 weeks.
Det er derfor nødvendigt nøje at vurdere fordele og risici, når Emtricitabine/Tenofovir disoproxil Zentiva anvendes til patienter med kreatininclearance &lt; 60 ml/min, og nyrefunktionen bør monitoreres omhyggeligt.
Therefore, a careful benefit-risk assessment is needed when Emtricitabine/Tenofovir disoproxil Zentiva is used in patients with creatinine clearance &lt; 60 ml/min, and renal function should be closely monitored.
Steady state farmakokinetik af tenofovir blev evalueret hos 8 HIV 1-inficerede unge patienter (i alderen 12 til &lt; 18 år) med kropsvægt ≥ 35 kg og hos 23 HIV 1-inficerede børn i alderen 2 til &lt; 12 år.
Steady-state pharmacokinetics of tenofovir were evaluated in 8 HIV-1 infected adolescent patients (aged 12 to &lt; 18 years) with body weight ≥ 35 kg and in 23 HIV1 infected children aged 2 to &lt; 12 years.
I uge 48 havde seks unge i gruppen, der fik tenofovirdisoproxil, og en ung i placebogruppen signifikante fald i BMD i lænderygsøjlen (defineret som fald på &gt; 4%).
At week 48, six adolescents in the tenofovir disoproxil group and one adolescent in the placebo group had significant lumbar spine BMD loss (defined as &gt; 4% loss).
Hvis der findes kliniske symptomer svarende til akut virusinfektion, og der er mistanke om nylige ( &lt; 1 måned) eksponeringer for HIV 1, bør brugen af Emtricitabine/Tenofovir disoproxil Zentiva udsættes mindst en måned og HIV 1-status bekræftes før påbegyndelse af Emtricitabine/Tenofovir disoproxil Zentiva som profylakse før eksponering.
If clinical symptoms consistent with acute viral infection are present and recent ( &lt; 1 month) exposures to HIV-1 are suspected, use of Emtricitabine/Tenofovir disoproxil Zentiva should be delayed for at least one month and HIV-1 status reconfirmed before starting Emtricitabine/Tenofovir disoproxil Zentiva for pre-exposure prophylaxis.
Graden af nedsat nyrefunktion blev defineret i henhold til kreatininclearance (CrCl) ved baseline (normal nyrefunktion med CrCl &gt; 80 ml/min; let nedsat nyrefunktion med CrCl = 50 - 79 ml/min; moderat nedsat nyrefunktion med CrCl = 30 - 49 ml/min og svært nedsat nyrefunktion med CrCl = 10 - 29 ml/min).
The degree of renal impairment was defined according to baseline creatinine clearance (CrCl) (normal renal function when CrCl &gt; 80 ml/min; mild impairment with CrCl = 50 - 79 ml/min; moderate impairment with CrCl = 30 - 49 ml/min and severe impairment with CrCl = 10 - 29 ml/min).
Sekundære virkningsanalyser i løbet af de 144 uger omfattede andelen af patienter med HIV 1-rnakoncentrationer &lt; 400 eller &lt; 50 kopier/ml og en ændring i CD4-celletallet fra baseline.
Secondary efficacy analyses over 144 weeks included the proportion of patients with HIV-1 RNA concentrations &lt; 400 or &lt; 50 copies/ml, and change from baseline in CD4 cell count.
Emtricitabin/tenofovirdisoproxils renale sikkerhed er kun blevet undersøgt i meget begrænset omfang hos HIV 1-inficerede patienter med nedsat nyrefunktion (kreatininclearance &lt; 80 ml/min).
Renal safety with emtricitabine/tenofovir disoproxil has only been studied to a very limited degree in HIV-1 infected patients with impaired renal function (creatinine clearance &lt; 80 ml/min).
• M184V/I-mutationen udviklede sig hos 2/19 (10,5%) af de isolater, der blev analyseret fra patienter i emtricitabin/tenofovirdisoproxil/efavirenz-gruppen og hos 10/29 (34,5%) af de isolater, der blev analyseret fra lamivudin/zidovudin/efavirenz-gruppen (p-værdi &lt; 0,05; Fisher's Exact test, her sammenligning af alle patienterne fra henholdsvis emtricitabin/tenofovirdisoproxilgruppen med lamivudin/zidovudin-gruppen).
• The M184V/I mutation developed in 2/19 (10.5%) isolates analysed from patients in the emtricitabine/tenofovir disoproxil/efavirenz group and in 10/29 (34.5%) isolates analysed from the lamivudine/zidovudine/efavirenz group (p-value &lt; 0.05, Fisher's Exact test comparing the emtricitabine/tenofovir disoproxil group to the lamivudine/zidovudine group among all patients).
Hos HIV 1-inficerede unge (12 til &lt; 18 år) var de observerede BMD Z-scorer hos de forsøgspersoner, som fik tenofovirdisoproxil, lavere end hos de forsøgspersoner, der fik placebo.
In HIV-1 infected adolescents (aged 12 to &lt; 18 years), the BMD Z-scores observed in subjects who received tenofovir disoproxil were lower than those observed in subjects who received placebo.
Renale bivirkninger svarende til proksimal renal tubulopati er blevet rapporteret hos HIV 1-inficerede pædiatriske patienter i alderen 2 til &lt; 12 år i det kliniske studie GS-US-104-0352 (se pkt.
Renal adverse reactions consistent with proximal renal tubulopathy have been reported in HIV-1 infected paediatric patients aged 2 to &lt; 12 years in clinical study GS-US-104-0352 (see sections 4.8 and 5.1).
Anvendelse anbefales ikke til personer uden HIV 1-infektion med CrCl &lt; 60 ml/min., da dette ikke er undersøgt hos denne population (se pkt.
Use is not recommended in HIV-1 uninfected individuals with CrCl &lt; 60 ml/min as it has not been studied in this population (see sections 4.4 and 5.2).
Når manglende data fraregnes, havde 91% af patienterne i gruppen, der fik tenofovirdisoproxil, og 94% af patienterne i gruppen, der fik stavudin eller zidovudin, koncentrationer af HIV-1 rna på &lt; 400 kopier/ml i uge 48.
When missing data were excluded, 91% of patients in the tenofovir disoproxil treatment group and 94% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations &lt; 400 copies/ml at week 48.
En forsøgsperson, der fik tenofovirdisoproxil, og ingen forsøgspersoner, der fik stavudin eller zidovudin, havde signifikant fald ( &gt; 4%) i BMD i lænderygsøjlen i uge 48.
One tenofovir disoproxil treated subject and no stavudine or zidovudine treated subjects experienced significant ( &gt; 4%) lumbar spine BMD loss at week 48.
Svært nedsat nyrefunktion (CrCl &lt; 30 ml/min) og hæmodialysepatienter
Severe renal impairment (CrCl &lt; 30 ml/min) and haemodialysis patients
Emtricitabine/Tenofovir disoproxil Zentiva anbefales ikke til patienter med svært nedsat nyrefunktion (kreatininclearance &lt; 30 ml/min) og hos patienter, som skal have hæmodialyse, da de nødvendige dosisreduktioner ikke kan opnås med kombinationstabletten (se pkt.
The use of Emtricitabine/Tenofovir disoproxil Zentiva is not recommended in patients with severe renal impairment (creatinine clearance &lt; 30 ml/min) and in patients who require haemodialysis since appropriate dose reductions cannot be achieved with the combination tablet (see sections 4.2 and 5.2).
I uge 48 af behandlingen udviste 70% og 64% af patienterne HIV 1-rna &lt; 50 kopier/ml med henholdsvis en og to gange daglig behandling med lopinavir/ritonavir.
At 48 weeks, 70% and 64% of patients demonstrated HIV-1 RNA &lt; 50 copies/ml with the once and twice daily regimens of lopinavir/ritonavir, respectively.
Det bør overvejes at afbryde behandlingen med Emtricitabine/Tenofovir disoproxil Zentiva hos patienter, hvor kreatininclearance falder til &lt; 50 ml/min eller serumphosphat til &lt; 1,0 mg/dl (0,32 mmol/l).
Consideration should be given to interrupting treatment with Emtricitabine/Tenofovir disoproxil Zentiva in patients with creatinine clearance decreased to &lt; 50 ml/min or decreases in serum phosphate to &lt; 1.0 mg/dl (0.32 mmol/l).
I uge 48 havde 83% af patienterne i gruppen, der fik tenofovirdisoproxil, og 92% af patienterne i gruppen, der fik stavudin eller zidovudin, koncentrationer af HIV-1 rna på &lt; 400 kopier/ml.
At week 48, 83% of patients in the tenofovir disoproxil treatment group and 92% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations &lt; 400 copies/ml.
I et åbent, randomiseret, klinisk studie (GS-01-934) med antiretroviral-naive patienter blev der foretaget genotypebestemmelser på plasma-HIV 1-isolater fra alle patienter med bekræftet HIVrna &gt; 400 kopier/ml ved uge 48, 96 eller 144 eller på tidspunktet for tidlig seponering af forsøgsmedicinen.
In vivo - treatment of HIV-1 In an open-label randomised clinical study (GS-01-934) in antiretroviral-naïve patients, genotyping was performed on plasma HIV-1 isolates from all patients with confirmed HIV RNA &gt; 400 copies/ml at weeks 48, 96 or 144 or at the time of early study drug discontinuation.
I studie GS-US-104-0321 blev 87 HIV 1-inficerede behandlingserfarne patienter i alderen 12 til &lt; 18 år behandlet med tenofovirdisoproxil (n = 45) eller placebo (n = 42) samtidigt med et optimeret baggrundsregime (OBR) i 48 uger.
In study GS-US-104-0321, 87 HIV-1 infected treatment-experienced patients 12 to &lt; 18 years of age were treated with tenofovir disoproxil (n = 45) or placebo (n = 42) in combination with an optimised background regimen (OBR) for 48 weeks.
Vurderingen af bivirkninger i forbindelse med tenofovirdisoproxil er baseret på to randomiserede studier (studierne GS-US-104-0321 og GS-US-104-0352) hos 184 HIV 1-inficerede pædiatriske patienter (2 år til &lt; 18 år), som fik behandling med tenofovirdisoproxil (n = 93) eller placebo/aktiv komparator (n = 91) i kombination med andre antiretrovirale stoffer i 48 uger (se pkt.
Assessment of adverse reactions related to tenofovir disoproxil is based on two randomised trials (studies GS-US 104-0321 and GS-US-104-0352) in 184 HIV-1 infected paediatric patients (aged 2 to &lt; 18 years) who received treatment with tenofovir disoproxil (n = 93) or placebo/active comparator (n = 91) in combination with other antiretroviral agents for 48 weeks (see section 5.1).
Håndtering af nedsat nyrefunktion ved profylakse før eksponering Emtricitabin/tenofovirdisoproxil er ikke blevet undersøgt hos personer uden HIV 1-infektion med kreatininclearance f60 ml/min og anbefales derfor ikke til denne population.
Emtricitabine/tenofovir disoproxil has not been studied in HIV-1 uninfected individuals with creatinine clearance &lt; 60 ml/min and is therefore not recommended for use in this population.
HIV-1-rna &lt; 400 kopier/ml (TLOVR) p-værdi % forskel (95% CI)
HIV-1 RNA &lt; 400 copies/ml (TLOVR)
Hvis serumphosphat bekræftes at være &lt; 3,0 mg/dl (0,96 mmol/l) hos en pædiatrisk patient, der får Emtricitabine/Tenofovir disoproxil Zentiva, skal nyrefunktionen revurderes inden for en uge, herunder måling af blodglucose, blodkalium og uringlucose (se pkt.
If serum phosphate is confirmed to be &lt; 3.0 mg/dl (0.96 mmol/l) in any paediatric patient receiving emtricitabine/tenofovir disoproxil, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Hvis serumphosphat er &lt; 1,5 mg/dl (0,48 mmol/l) eller kreatininclearance reduceret til &lt; 60 ml/min- hos en person, der får Emtricitabine/Tenofovir disoproxil Zentiva som profylakse før eksponering, skal nyrefunktionen revurderes inden for en uge, herunder måling af blodglucose, blodkalium og uringlucose (se pkt.
If serum phosphate is &lt; 1.5 mg/dl (0.48 mmol/l) or creatinine clearance is decreased to &lt; 60 ml/min in any individual receiving Emtricitabine/Tenofovir disoproxil Zentiva for pre-exposure prophylaxis, renal function should be re evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Hvis serumphosphat er &lt; 1,5 mg/dl (0,48 mmol/l), eller kreatininclearance er reduceret til &lt; 50 ml/min hos patienter, der får Emtricitabine/Tenofovir disoproxil Zentiva, bør nyrefunktionen revurderes inden for en uge, herunder måling af blodglucose, blodkalium og uringlucose (se pkt.
If serum phosphate is &lt; 1.5 mg/dl (0.48 mmol/l) or creatinine clearance is decreased to &lt; 50 ml/min in any patient receiving Emtricitabine/Tenofovir disoproxil Zentiva, renal function should be reevaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
HIV -1-rna &lt; 50 kopier/ml (TLOVR) p-værdi % forskel (95% CI)
HIV-1 RNA &lt; 50 copies/ml (TLOVR)
Det bør overvejes at afbryde brugen af Emtricitabine/Tenofovir disoproxil Zentiva hos personer, hvor kreatininclearance er faldet til &lt; 60 ml/min- eller serumphosphat til &lt; 1,0 mg/dl (0,32 mmol/), ligesom det bør overvejes at afbryde behandlingen i tilfælde af progredierende fald i nyrefunktionen, når ingen anden årsag er blevet identificeret.
Consideration should be given to interrupting use of Emtricitabine/Tenofovir disoproxil Zentiva in individuals with creatinine clearance decreased to &lt; 60 ml/min or decreases in serum phosphate to &lt; 1.0 mg/dl (0.32 mmol/l).
Hyppighederne er defineret som: meget almindelige (≥ 1/10), almindelige (≥ 1/100 til 1/10), ikke almindelige (≥ 1/1.000 til &lt; 1/100).
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100).
Samlet set blev der ikke observeret nogen forskel i sikkerhed og virkning mellem ældre (i alderen ≥ 65 år) og yngre patienter (i alderen &lt; 65 år) i fase III-studiet.
No overall differences in safety or efficacy were observed between elderly (aged ≥ 65 years) and younger patients (aged &lt; 65 years) in the phase III study.
b Hazard ratio (Xofigo over placebo) &lt; 1 favoriserer Xofigo.
b Hazard ratio (Xofigo over placebo) &lt; 1 favours Xofigo.
En præspecificeret undergruppeanalyse viste også, at den samlede overlevelse ikke var signifikant forbedret hos patienter med et totalt alkalisk fosfatase &lt; 220 E/l.
A pre-specified subgroup analysis also showed that overall survival was not significantly improved in patients with a total ALP &lt; 220 U/L.
• 16 % af patienterne havde &lt; 6 knoglemetastaser, 44 % af patienterne havde fra 6 til
• 16% of patients had &lt; 6 bone metastases, 44% of patients had between 6 and 20 bone metastases,
En statistisk signifikant samlet overlevelsesfordel ved behandlingen kunne ikke vises i undergrupperne af patienter med færre end 6 metastaser (HR for radium-223 vs. placebo 0,901; 95% CI [0,553-1,466], p=0,674) eller totalt basisk fosfatase ved baseline &lt; 220 E/l (HR 0,823; 95 % CI [0,633-1,068], p=0,142) i fase III ALSYMPCA-studiet.
A statistically significant overall survival benefit of treatment could not be demonstrated in the subgroups of patients with fewer than 6 metastases (HR for radium-223 to placebo 0.901; 95% CI [0.553 -1.466], p=0.674) or a baseline total alkaline phosphatase (ALP) &lt; 220 U/L (HR 0.823; 95% CI [0.633 -1.068], p=0.142) in the phase III ALSYMPCA study.
Der foreligger ingen data for patienter med svært (CLCR &lt; 30 ml/min) nedsat nyrefunktion eller nyresygdom i slutstadiet.
No data are available for patients with severe (CLCR &lt; 30 mL/min) renal impairment or end-stage renal disease.
[median antal måneder] Hazard ratio &lt; 1 favoriserer Xofigo
Time-to-event analysis (95% CI) [no. (%) of patients] [median no. of months] Hazard ratio &lt; 1 favours Xofigo p-value
&lt; 7 dage (inden for en cyklus)
&lt; 7 days (within a cycle)
Infektion omfatter ogsÃ¥ andre typer infektion (11 %).
a Infection also includes other types of infection (11%).
Bemærk, at patienter kan have haft &gt; 1 type infektion.
Note: patients may have had &gt; 1 type of infection.
BESPONSAs sikkerhed og virkning i hos børn 0-18 år er ikke klarlagt.
The safety and efficacy of BESPONSA in children aged 0 to &lt; 18 years have not been established.
Infusionsslangen behÃ¸ver ingen beskyttelse mod lys.
The infusion line does not need to be protected from light.
BESPONSA forbedrede OS i forhold til investigators valg af kemoterapi for alle stratificeringsfaktorer, herunder varighed af første remission ≥ 12 måneder, status af salvagebehandling 1 og alder &lt; 55 år ved randomisering.
BESPONSA improved OS versus Investigator's choice of chemotherapy for all stratification factors including duration of first remission ≥12 months, Salvage 1 status, and age at randomisation &lt; 55 years.
&gt; 28 dage
&gt; 28 days
Bemærk, at patienter kan have haft &gt; 1 type blødning.
Note: patients may have had &gt; 1 type of haemorrhage.
Bivirkninger er opstillet efter systemorganklasse og hyppighed i følgende grupperinger: 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 estimeres ud fra forhåndenværende data).
The adverse reactions are presented by system organ class (SOC) and frequency categories, defined using the following convention: 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).
Total bilirubin &gt; 1,5 × ULN og ASAT/ALAT &gt; 2,5 × ULN
Total bilirubin &gt; 1.5 × ULN and AST/ALT &gt; 2.5 × ULN
2-sidet p-værdi &lt; 0,0001 BESPONSA (N = 164)
2-sided p-value &lt; 0.0001 BESPONSA (N=164)
En stigning i QTcF intervallet på &gt; 450 msek blev observeret hos 26/162 (16 %) patienter.
An increase in QTcF interval of &gt; 450 msec was observed in 26/162 (16%) patients.
I forhold til andre risikofaktorer blev VOD/SOS rapporteret hos 6/11 (55 %) patienter, der fik et HSCT-konditionerende regime, der indeholdt 2 alkylerende midler og 9/53 (17 %) patienter, der fik et HSCT-konditionerende regime, der indeholdt 1 alkylerende middel, 7/17 (41 %) patienter, der var ≥ 55 år og 11/62 (18 %) patienter, der var &lt; 55 år, og 7/12 (58 %) patienter med serumbilirubin ≥ ULN inden HSCT og hos 11/67 (16 %) patienter med serumbilirubin &lt; ULN inden HSCT.
Regarding other risk factors, VOD/ SOS was reported in 6/11 (55%) patients who received a HSCT conditioning regimen containing 2 alkylating agents and 9/53 (17%) patients who received a HSCT conditioning regimen containing 1 alkylating agent, 7/17 (41%) patients who were ≥ 55 years old and 11/62 (18%) patients who were &lt; 55 years old, and 7/12 (58%) patients with a serum bilirubin ≥ ULN prior to HSCT and in 11/67 (16%) patients with a serum bilirubin &lt; ULN prior to HSCT.
2-sidet p-værdi &lt; 0,0001
2-sided p-value &lt; 0.0001
Overvejes BESPONSA som behandling mod recidiverende eller refraktær B-celle ALL, skal baselineværdien for CD22-positivitet være &gt; 0% inden behandlingsstart, målt ved hjælp af en valideret og sensitiv test (se pkt.
When considering the use of BESPONSA as a treatment for relapsed or refractory B cell ALL, baseline CD22 positivity of &gt; 0% using a validated and sensitive assay is required prior to initiating treatment (see section 5.1).
Gennemsnitsalder var 47 år (interval: 18-79 år), varigheden af første remission var &lt; 12 måneder for 206 (63%) af patienterne og 55 (17%) af patienterne havde fået HSCT før behandling med BESPONSA eller investigators valg af kemoterapi.
The median age was 47 years (range: 18-79 years), 206 (63%) patients had a duration of first remission &lt; 12 months, and 55 (17%) patients had undergone an HSCT prior to receiving BESPONSA or Investigator's choice of chemotherapy.
Hos 3 patienter med nedsat leverfunktion, defineret af NCI ODWG kategori C (total bilirubin &gt; 1,5-3 × ULN og ASAT på alle niveauer) og 1 patient med nedsat leverfunktion, defineret af NCI ODWG kategory D (total bilirubin &gt; 3 × ULN og ASAT af alle niveauer) lod inotuzumab ozogamicinclearance ikke til at være reduceret.
In 3 patients with hepatic impairment defined by NCI ODWG category C (total bilirubin &gt; 1.5-3 × ULN and AST any level) and 1 patient with hepatic impairment defined by NCI ODWG category D (total bilirubin &gt; 3 × ULN and AST any level), inotuzumab ozogamicin clearance did not appear to be reduced.
Der er begrænset sikkerhedsinformation fra patienter med total bilirubin &gt; 1,5 × ULN og ASAT/ALAT &gt; 2,5 × ULN inden dosering.
There is limited safety information available in patients with total bilirubin &gt; 1.5 × ULN and AST/ALT &gt; 2.5 × ULN prior to dosing.
MRD-negativitet blev defineret ved flowcytometri som leukæmiceller bestående af &lt; 1 × 10 kerneholdige celler i knoglemarven.
c MRD negativity was defined by flow cytometry as leukaemic cells comprising &lt; 1 × 10-4 ( &lt; 0.01%) of bone marrow nucleated cells.
Stigninger i QTcF interval på &gt; 450 msek og &gt; 500 msek blev observeret hos henholdsvis 26/162 (16 %) og ingen af patienterne i inotuzumab ozogamicin-armen versus 12/124 (10 %) og 1/124 (1 %) af patienterne i behandlingsarmen med investigators valg af kemoterapi (se pkt.
Increases in QTcF interval of &gt; 450 msec and &gt; 500 msec were observed in 26/162 (16%) and none of the patients in the inotuzumab ozogamicin arm versus 12/124 (10%) and 1/124 (1%) patients in the Investigator's choice of chemotherapy arm, respectively (see section 4.8).
Risikorate [95 % CI] = 0,450 [0,348-0,581] 2-sidet p-værdi &lt; 0,0001
Hazard ratio [95% CI] = 0.450 [0.348-0.581] 2-sided p-value &lt; 0.0001
Baseret på en populationsfarmakokinetisk analyse af 765 patienter var clearance af inotuzumab ozogamicin hos patienter med nedsat leverfunktion, defineret af National Cancer Institute Organ Dysfunction Working Group (NCI ODWG) kategori B1 (total bilirubin ≤ ULN og ASAT &gt; ULN, n = 133) eller B2 (total bilirubin &gt; 1,0-1,5 × ULN og ASAT af alle niveauer, n = 17) den samme som hos patienter med normal leverfunktion (total bilirubin/ASAT ≤ ULN, n = 611) (se pkt.
Based on a population pharmacokinetic analysis in 765 patients, the clearance of inotuzumab ozogamicin in patients with hepatic impairment defined by National Cancer Institute Organ Dysfunction Working Group (NCI ODWG) category B1 (total bilirubin ≤ ULN and AST &gt; ULN; n=133) or B2 (total bilirubin &gt; 1.0-1.5 × ULN and AST any level; n=17) was similar to patients with normal hepatic function (total bilirubin/AST ≤ ULN; n=611) (see section 4.2).
Risikorate [95% CI] = 0,471 [0,366-0,606] 2-sidet p-værdi &lt; 0,0001
[2.8 to 4.6] Hazard ratio [95% CI] = 0.471 [0.366-0.606] 2-sided p-value &lt; 0.0001
9/l, og/eller trombocyttallet &lt; 50 × 10
ANC was &lt; 1 × 109/L and/or platelet count was &lt; 50 × 109/La
ANC var &lt; 1 × 10
ANC was ≥ 1 × 109/L
CR defineres som &lt; 5% blaster i knoglemarven og fravær af leukæmiske blaster i perifert blod, fuld restitution af perifere blodtal (trombocytter ≥ 100 × 109/l og ANC ≥ 1 × 109/l) og resolution af eventuel ekstramedullær sygdom.
c CR is defined as &lt; 5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts, full recovery of peripheral blood counts (platelets ≥ 100 × 109/L and ANC ≥ 1 × 109/L) and resolution of any extramedullary disease.