FrancophonIA/ELRC3.0 huggingface dataset:
English: Bortezomib Hospira should not be used during pregnancy unless the clinical condition of the woman requires treatment with Bortezomib Hospira.
Danish: Bortezomib Hospira bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med bortezomib.
English: If you have mantle cell lymphoma and are given the medicine rituximab with bortezomib you should tell your doctor:
Danish: Hvis du har mantle-celle-lymfom og får lægemidlet rituximab sammen med bortezomib, skal du fortælle det til din læge:
English: The other ingredient is mannitol (E421).
Danish: Øvrige indholdsstoffer: mannitol (E 421).
English: • The reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Danish: • Den rekonstituerede opløsning indgives subkutant i låret (højre eller venstre) eller abdomen (højre eller venstre side).
English: Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving bortezomib.
Danish: Posteriort reversibelt encefalopatisk syndrom (PRES) Der er indberettet PRES hos patienter, der fik bortezomib.
English: Overall complete response (CR+CRu)
Danish: Samlet komplet respons (CR+CRu)
English: Incidence of death from “Progressive disease” was 18% in the subcutaneous group and 9% in the intravenous group.
Danish: Dødsfald som følge af “progressiv sygdom” forekom hos 18% i den subkutane gruppe og hos 9% i den intravenøse gruppe.
English: 42.9% and 10.4% of patients in the BR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively.
Danish: Henholdsvis 42,9% og 10,4% af patienterne i BR-CAP-gruppen var i alderen 65-74 år og ≥ 75 år.
English: It is specifically designed to inhibit the chymotrypsin-like activity of the 26S proteasome in mammalian cells.
Danish: Den er specifikt designet til at hæmme 26S-proteasomets chymotrypsinlignende aktivitet i pattedyrceller.
English: Undesirable effects in Table 7 were considered by the investigators to have at least a possible or probable causal relationship to bortezomib.
Danish: Bivirkningerne i tabel 7 blev af investigatorerne anset for som et minimum at have en mulig eller sandsynlig kausal sammenhæng med bortezomib.
English: The mean elimination half-life (t1/2) of bortezomib upon multiple dosing ranged from 40-193 hours.
Danish: Den gennemsnitlige eliminationshalveringstid (t1/2) for bortezomib efter gentagne doser var fra 40-193 timer.
English: Hypertension*, Hypotension*, Orthostatic hypotension
Danish: Hypertension*, hypotension*, ortostatisk hypotension
English: Be sure that the correct dose is being given for the intravenous route of administration (1 mg/ml).
Danish: Kontrollér, at den korrekte dosis anvendes til intravenøs administration (1 mg/ml).
English: Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, the CYP2D6 poor metaboliser phenotype is not expected to affect the overall disposition of bortezomib.
Danish: På baggrund af det begrænsede bidrag (7%) fra CYP2D6 til metaboliseringen af bortezomib forventes det ikke, at CYP2D6-fænotypen, som metaboliserer dårligt, påvirker den samlede disponering for bortezomib.
English: In the BR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
Danish: I BR-CAP-gruppen fik 22,5% af patienterne thrombocyttransfusioner sammenlignet med 2,9% af patienterne i R-CHOP-gruppen.
English: p-value is for the non-inferiority hypothesis that the SC arm retains at least 60% of the response rate in the IV arm.
Danish: p-værdien er for hypotesen om noninferioritet, at den subkutane gruppe fastholder mindst 60% af responsraten i den intravenøse gruppe
English: Other reported hepatic reactions include increases in liver enzymes, hyperbilirubinaemia, and hepatitis.
Danish: Andre rapporter om leverreaktioner omfatter stigninger i leverenzymtal, hyperbilirubinæmi og hepatitis.
English: Table 11: Efficacy results following the final survival update to VISTA study Efficacy endpoint
Danish: Tabel 11: Effektresultater efter den endelige opdatering af overlevelse i VISTA-forsøget Effektendepunkt
English: Melphalan (9 mg/m 2) and prednisone (60 mg/m 2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.
Danish: Melphalan (9 mg/m 2) og prednison (60 mg/m 2) gives begge gennem munden på dag 1, 2, 3 og 4 i den første uge af hver cyklus.
English: TTP, days [95% CI] 1 year survival, % [95% CI]
Danish: TTP, dage [95% CI] 1-års overlevelse, % [95% CI]
English: OR; 95% CI; P value
Danish: OR; 95% CI; P-værdi
English: The overall best response rate (CR + PR), to retreatment in 130 patients was 38.5% (95% CI: 30.1, 47.4).
Danish: Den samlede bedste responsrate (CR + PR) ved genbehandling af 130 patienter var 38,5% (95% CI: 30,1; 47,4).
English: • rifampicin, an antibiotic used to treat bacterial infections
Danish: • rifampicin, et antibiotikum, som bruges til behandling af bakterieinfektioner
English: Cardiovascular safety pharmacology studies in monkeys and dogs show that intravenous doses approximately two to three times the recommended clinical dose on a mg/m2 basis are associated with increases in heart rate, decreases in contractility, hypotension and death.
Danish: Farmakologiske forsøg af den kardiovaskulære sikkerhed hos aber og hunde viser, at intravenøse doser på cirka 2-3 gange den anbefalede kliniske dosis på mg/m2-basis er forbundet med pulsstigninger, fald i kontraktilitet, hypotension og dødsfald.
English: The solution should be injected subcutaneously, at a 45-90° angle.
Danish: Opløsningen skal indgives subkutant i en vinkel på 45-90 °.
English: • Flush the peripheral or intravenous catheter with sterile, 9 mg/ml (0.9%) sodium chloride solution.
Danish: • Skyl det perifere eller intravenøse kateter igennem med steril 9 mg/ml (0,9%) natriumchloridinjektionsvæske.
English: The Reconstitution, dosing and administration booklet shall contain the following key elements:
Danish: Hæftet om rekonstitution, dosering og administration skal indeholde følgende hovedpunkter:
English: Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264).
Danish: Perifer neuropati ≥ grad 3 forekom hos 6% af patienterne i den subkutane behandlingsgruppe sammenlignet med 16% i den intravenøse behandlingsgruppe (p=0,0264).
English: Grade 2 with pain or Grade 3 (severe symptoms; limiting self care ADL***)
Danish: Grad 2 med smerter eller grad 3 (svære symptomer; begrænsning i ADL med personlig pleje***)
English: Orthostatic/postural hypotension was not acutely related to bolus infusion of bortezomib.
Danish: Ortostatisk/postural hypotension var ikke akut relateret til bolusinfusionen af bortezomib.
English: Patients should be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML as part of the differential diagnosis of
Danish: Patienterne bør kontrolleres regelmæssigt for nye eller tiltagende neurologiske symptomer eller tegn, der kunne tyde på PML, som led i differentialdiagnosticeringen af lidelser i centralnervesystemet.
English: Table 8 Adverse reactions in patients with Mantle cell lymphoma treated with BR-CAP in a clinical trial.
Danish: Tabel 8: Bivirkninger hos patienter med mantle-celle-lymfom, som er behandlet med BR-CAP i et klinisk forsøg.
English: Very Common Hair disorder* Common
Danish: Meget almindelig Hårsygdom* Almindelig
English: Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m2 dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations.
Danish: Efter en intravenøs bolusinjektion eller subkutan injektion af en dosis på 1,3 mg/m til patienter med myelomatose (n=14 i den intravenøse gruppe, n=17 i den subkutane gruppe) var den totale systemiske eksponering efter gentagne doser (AUClast) ens for subkutan og intravenøs administration.
English: • advice on how to reduce the risk of mix-up of IV and SC reconstituted syringes
Danish: • Rådgivning om, hvordan man nedsætter risikoen for forveksling af rekonstituerede sprøjter til i.v.
English: 9/l on a Bortezomib Hospira dosing day (other than day 1)
Danish: 9/l på en dag med dosering af Bortezomib Hospira (bortset fra dag 1)
English: The matched-pair analysis is a statistical method in which patients in the treatment group (e.g. bortezomib in combination with dexamethasone) and patients in the comparison group (e.g. bortezomib) are made comparable with respect to confounding factors by individually pairing study subjects.
Danish: "Matchede par"-analysen er en statistisk metode, hvor patienter i behandlingsgruppen (f.eks. bortezomib i kombination med dexamethason) og patienter i sammenligningsgruppen (f.eks. bortezomib) gøres sammenlignelige med hensyn til forvekslelige faktorer ved individuelt at sammensætte forsøgspersonerne i par.
English: Response rate population e n=668
Danish: Responsrate Population e n=668
English: Time to first response in CR + PR Median
Danish: Tid indtil første respons i CR + PR Medianværdi
English: You may also be given bortezomib together with the medicines pegylated liposomal doxorubicin or dexamethasone.
Danish: Du kan ligeledes få bortezomib sammen med lægemidlerne pegyleret liposomal doxorubicin eller dexamethason.
English: Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
Danish: Omfatter alle radiologiske CR+CRu+PR efter IRC uanset verificering ved knoglemarv og LDH.
English: In addition to peripheral neuropathy, there may be a contribution of autonomic neuropathy to some adverse reactions such as postural hypotension and severe constipation with ileus.
Danish: Ud over perifer neuropati kan der forekomme autonom neuropati ved nogle bivirkninger, f.eks. postural hypotension og svær obstipation med ileus.
English: The majority of the patients in both groups completed treatment, 80% in the BR-CAP group and 82% in the R-CHOP group.
Danish: Størstedelen af patienterne i begge grupper fuldførte behandlingen, 80% i BR-CAP-gruppen og 82% i R-CHOP-gruppen.
English: It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of Bortezomib Hospira therapy.
Danish: Det anbefales ligeledes, at responderende patienter, som ikke opnår komplet remission, gennemgår i alt 8 behandlingscyklusser med Bortezomib Hospira.
English: The overall incidence of diarrhoea, gastrointestinal and abdominal pain, asthenic conditions, upper respiratory tract infections and peripheral neuropathies were 12%-15% lower in the subcutaneous group than in the intravenous group.
Danish: Den samlede forekomst af diarré, smerter i mave-tarm-kanalen og abdomen, asteniske tilstande, øvre luftvejsinfektioner og perifere neuropatier var 12-15% lavere i den subkutane gruppe end i den intravenøse gruppe.
English: TTP, months (95% CI)
Danish: TTP, måneder (95% CI)
English: Dexamethasone was administered in combination with bortezomib to 83 patients in Cycle 1 with an additional 11 patients receiving dexamethasone during the course of bortezomib retreatment cycles.
Danish: Dexamethason blev administreret i kombination med bortezomib til 83 patienter i cyklus 1, mens yderligere 11 patienter fik dexamethason i løbet af de efterfølgende cyklusser med genbehandling med bortezomib.
English: Bortezomib Hospira should be discontinued if serious reactions occur.
Danish: Bortezomib Hospira skal seponeres, hvis der opstår alvorlige reaktioner.
English: Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2 -microglobulin, albumin, and region.
Danish: Estimatet af hazards ratio er baseret på en Cox proportional hazard-model justeret for stratifikationsfaktorer: β2 -mikroglobulin, albumin og region.
English: The fraction of bortezomib bound to plasma proteins was not concentration-dependent.
Danish: Fraktionen af bortezomib bundet til plasmaproteiner er ikke koncentrationsafhængig.
English: The solution will be clear and colourless, with a final pH of 4 to 7.
Danish: Opløsningen vil være klar og farveløs med en endelig pH-værdi på 4-7.
English: The concentration of the resulting solution will be 1 mg/ml.
Danish: Koncentrationen i den færdige opløsning vil være 1 mg/ml.
English: CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio; OR=Odds Ratio; ITT=Intent to Treat
Danish: CR = komplet respons; CRu = komplet respons ubekræftet; PR = partielt respons; CI = konfidensinterval, HR = hazard ratio; OR = odds ratio; ITT = intent to treat
English: The concentration of the resulting solution will be 2.5 mg/ml.
Danish: Koncentrationen i den færdige opløsning vil være 2,5 mg/ml.
English: Bortezomib treatment is very commonly associated with haematological toxicities (thrombocytopenia, neutropenia and anaemia).
Danish: Behandlingen med bortezomib forbindes meget ofte med hæmatologisk toksicitet (thrombocytopeni, neutropeni og anæmi).
English: Very Common Thrombocytopenia*, Febrile neutropenia, Neutropenia*,
Danish: Meget almindelig Thrombocytopeni*, febril neutropeni, neutropeni*,
English: Be sure that the correct dose is being given for the subcutaneous route of administration (2.5 mg/ml).
Danish: Kontrollér, at den korrekte dosis anvendes til subkutan administration (2,5 mg/ml).
English: Clinical efficacy with subcutaneous administration of bortezomib in patients with relapsed/refractory multiple myeloma
Danish: Klinisk virkning ved subkutan administration af bortezomib til patienter med recidiverende/refraktær myelomatose
English: • Hair loss and abnormal hair texture
Danish: • Hårtab og unormal hårtekstur
English: In the Phase III study, treatment with bortezomib led to a significantly longer time to progression, a significantly prolonged survival and a significantly higher response rate, compared to treatment with dexamethasone (see Table 14), in all patients as well as in patients who have received 1 prior line of therapy.
Danish: I fase III-forsøget førte behandling med bortezomib til signifikant længere tid indtil progression, en signifikant længere overlevelse og en signifikant højere responsrate sammenlignet med behandling med dexamethason (se tabel 14) hos alle patienter samt hos patienter, som tidligere havde fået én behandling.
English: Geometric mean (%CV) clearance was 7.79 (25%) L/hr/m2, volume of distribution at steady-state was 834 (39%) L/m2, and the elimination half-life was 100 (44%) hours.
Danish: Den geometriske gennemsnitlige (%CV) clearance er 7,79 (25%) l/t/m2, fordelingsvolumen ved steady state er 834 (39%) l/m2, og eliminationshalveringstiden er 100 (44%) timer.
English: Patients who did not obtain an optimal response (less than Complete Response [CR]) to therapy with bortezomib alone after 4 cycles were allowed to receive dexamethasone 20 mg daily on the day of and after bortezomib administration.
Danish: Patienter, der ikke opnåede optimalt respons (mindre end komplet respons [CR]) på behandling med bortezomib alene efter 4 cyklusser, fik desuden dexamethason 20 mg dagligt dagen før og efter administration af bortezomib.
English: In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure (such as fluids, pressors, and/or inotropic agents) and body temperature (see sections 4.2 and 4.4).
Danish: I tilfælde af overdosering skal patientens vitale funktioner monitoreres, og der skal ydes relevant, understøttende behandling for at opretholde blodtryk (f.eks. væske, pressorer og/eller inotrope midler) og legemstemperatur (se pkt.
English: • Heart problems to include heart attack, angina
Danish: • Hjerteproblemer, herunder hjerteanfald, angina pectoris
English: Patients eligible for stem cell transplantation
Danish: Dosisjustering til transplantationsegnede patienter
English: Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib
Danish: Tabel 15: Resumé af effektanalyser med sammenligning af subkutan og intravenøs administration af bortezomib
English: Include all CR+CRu, by IRC, bone marrow and LDH.
Danish: Omfatter alle CR + CRu, efter IRC, knoglemarv og LDH.
English: Thrombocytopenia*, Neutropenia*, Anaemia*
Danish: Thrombocytopeni*, neutropeni*, anæmi*
English: • Difficulty or problems in sleeping
Danish: • Søvnbesvær eller søvnproblemer
English: It is recommended that patients be carefully monitored for symptoms of neuropathy such as a burning sensation, hyperesthesia, hypoesthesia, paraesthesia, discomfort, neuropathic pain or weakness.
Danish: Det anbefales, at patienterne monitoreres nøje for symptomer på neuropati, f.eks. brændende fornemmelse, hyperæstesi, hypæstesi, paræstesi, ubehag, neuropatiske smerter eller svækkelse.
English: The reconstituted solution is clear and colourless, with a final pH of 4 to 7.
Danish: Den rekonstituerede opløsning er klar og farveløs med en endelig pH-værdi på 4-7.
English: No new safety concerns were observed when bortezomib was added to the standard paediatric pre B cell ALL chemotherapy backbone.
Danish: Der blev ikke observeret nogen nye sikkerhedsmæssige problemer, når bortezomib blev tilføjet til standardregimet med kemoterapi for pædiatrisk præ-B-celleALL.
English: Bortezomib is highly selective for the proteasome.
Danish: Bortezomib er særdeles selektivt for proteasomet.
English: Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with bortezomib treatment.
Danish: Gastrointestinal toksicitet, herunder kvalme, diaré, opkastning og obstipation, er meget almindelig ved behandling med bortezomib.
English: Also included are adverse drug reactions identified in the BR-CAP arm that were considered by investigators to have at least a possible or probable causal relationship to bortezomib based on historical data in the multiple myeloma studies.
Danish: Den indeholder desuden bivirkninger, som blev identificeret i BR-CAP-gruppen, og som af investigatorerne blev anset for som et minimum at have en mulig eller sandsynlig kausal sammenhæng med bortezomib, baseret på historiske data i myelomatose-forsøgene.
English: The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511;95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Danish: Analysen viste forbedret ORR (CR+PR) (odds ratio 3,769; 95% CI 2,045-6,947; p < 0,001), PFS (hazard ratio 0,511; 95% CI 0,309-0,845; p=0,008), TTP (hazard ratio 0,385; 95% CI 0,212-0,698; p=0,001) for bortezomib kombineret med dexamethason sammenlignet med monoterapi med bortezomib.
English: The median duration of complete response was 42.1 months in the BR-CAP group compared with 18 months in the RCHOP group.
Danish: Medianvarigheden af komplet respons var 42,1 måneder i BR-CAP-gruppen sammenlignet med 18 måneder i R-CHOP-gruppen.
English: In addition, the incidence of Grade 3 or higher peripheral neuropathies was 10% lower, and the discontinuation rate due to peripheral neuropathies 8% lower for the subcutaneous group as compared to the intravenous group.
Danish: Desuden er forekomsten af perifere neuropatier ≥ grad 3 10% lavere, og seponeringsraten på grund af perifer neuropati er 8% lavere i den subkutane gruppe end i den intravenøse gruppe.
English: In the Phase II study, patients who did not obtain an optimal response to therapy with bortezomib alone were able to receive high-dose dexamethasone in conjunction with bortezomib.
Danish: I fase II-forsøget kunne de patienter, som ikke havde optimalt respons på behandlingen med bortezomib alene, få højdosis dexamethason sammen med bortezomib.
English: p-value g=0.275
Danish: p-værdi g=0,275
English: • If platelet counts < 25,000 cells/μL or ANC < 750 cells/μL on a Bortezomib Hospira dosing day (other than Day 1 of each cycle)
Danish: • Hvis thrombocyttallet er < 25.000 celler/μl eller ANC er < 750 celler/μl l på en dag med dosering af Bortezomib Hospira (bortset fra dag 1 i hver cyklus)
English: The median age of the patients in the study was 71 years, 50% were male, 88% were Caucasian and the median Karnofsky performance status score for the patients was 80.
Danish: Medianalderen hos patienterne i forsøget var 71 år, 50% var mænd, 88% var af kaukasisk oprindelse, og medianscoren for Karnofsky performance status var 80.
English: • Platelet counts should be ≥ 100,000 cells/μL and the absolute neutrophils count (ANC) should be
Danish: • Thrombocyttal skal være ≥ 100.000 celler/μl, og absolut neutrofiltal (ANC) skal være ≥ 1.500
English: • ritonavir, used to treat HIV infection
Danish: • ritonavir, der bruges til behandling af hiv-infektion
English: One hundred and thirty patients (≥ 18 years of age) with multiple myeloma who previously had at least partial response on a bortezomib -containing regimen were retreated upon progression.
Danish: 130 patienter (≥ 18 år) med myelomatose, som tidligere havde haft mindst partielt respons på et bortezomib-holdigt regime, fik ny behandling ved progression.
English: Higher incidences were also noted for infections with Grade ≥ 3 neutropenia (24% versus 19% in Block 1 and 22% versus 11% in Block 2), increased ALT (17% versus 8% in Block 2), hypokalaemia (18% versus 6% in Block 1 and 21% versus 12% in Block 2) and hyponatraemia (12% versus 5% in Block 1 and 4% versus 0 in Block 2).
Danish: Der blev desuden noteret højere forekomst af infektioner med neutropeni grad ≥ 3 (24% vs. 19% i blok 1 og 22% vs. 11% i blok 2), forhøjet ALAT (17% vs. 8% i blok 2), hypokaliæmi (18% vs. 6% i blok 1 og 21% vs. 12% i blok 2) og hyponatriæmi (12% vs. 5% i blok 1 og 4% vs. 0% i blok 2).
English: Because bortezomib is a cytotoxic agent and can rapidly kill malignant plasma cells, the complications of tumour lysis syndrome may occur.
Danish: Da bortezomib er et cytotoksisk stof, som hurtigt kan dræbe maligne plasmaceller, kan der opstå komplikationer i form af tumorlysesyndrom.
English: Inhibition of the proteasome results in cell cycle arrest and apoptosis.
Danish: Hæmning af proteasomet fører til cellecyklusstop og apoptose.
English: Bortezomib Hospira contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Danish: Bortezomib Hospira indeholder det aktive stof bortezomib, som er en såkaldt proteasomhæmmer.
English: In a study in previously untreated mantle cell lymphoma patients, 42.9% and 10.4% of patients exposed to bortezomib were in the range 65-74 years and ≥ 75 years of age, respectively.
Danish: I et forsøg med patienter med tidligere ubehandlet mantle-celle-lymfom var henholdsvis 42,9% og 10,4% af de patienter, der fik bortezomib, i alderen 65-74 år og ≥ 75 år.
English: Acute development or exacerbation of congestive heart failure, and/or new onset of decreased left ventricular ejection fraction has been reported during bortezomib treatment.
Danish: Der er indberettet akut udvikling eller forværring af kronisk venstresidig hjerteinsufficiens og/eller ny forekomst af nedsat ejektionsfraktion fra venstre ventrikel ved behandling med bortezomib.
English: It is not known whether bortezomib is excreted in human milk.
Danish: Det er ukendt, om bortezomib udskilles i modermælk.
English: The incidence of death on treatment was 5% in the subcutaneous treatment group and 7% in the intravenous treatment group.
Danish: Forekomsten af dødsfald efter behandlingen var 5% i den subkutane gruppe og 7% i den intravenøse gruppe.
English: • If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle
Danish: 4 eller thrombocytopeni, eller der observeres thrombocytopeni med blødning i den foregående cyklus
English: CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate;
Danish: CI = konfidensinterval; CR = komplet respons; nCR = næsten komplet respons; ITT = intent to treat; RR = responsrate;