natgillin/translations-raw huggingface dataset:
De hyppigst indberettede andre samtidige sygdomme (med en cut-off på 30% eller derover) i MedDRA-systemet var: Vaskulære sygdomme (73%), hjertesygdomme (46%), sygdomme i mavetarm-kanalen (38%), stofskifte- og ernæringssygdomme (40%), sygdomme i nyrer og urinveje (38%), sygdomme i knogler, led, muskler og bindevæv (33%).
The most frequently reported coexisting medical conditions (using a cut off of 30% or higher), in the MedDRA body systems are: Vascular disorders (73%), Cardiac disorders (46%), Gastrointestinal disorders (38%), Metabolism and nutrition disorders (40%), Renal and urinary disorders (38%), Musculoskeletal and connective tissue disorders (33%).
Intravenøst kortikosteroid1,4(obligatorisk for kronisk lymfatisk leukæmi og anbefalet for follikulært lymfom)
Intravenous corticosteroid1,4 (mandatory for CLL, recommended for FL)
Kronisk lymfatisk leukæmi (i kombination med chlorambucil1)
Chronic lymphocytic leukaemia (in combination with chlorambucil1)
Dette vil inkludere 3 doser af Gazyvaro i løbet af 28 dage: 1. dag - første del af din 1. dosis (100 mg) 2. dag eller 1. dag (fortsat) - anden del af 1. dosis (900 mg) 8. dag - fuld dosis (1000 mg)
Cycle 1 - this will include three doses of Gazyvaro in the 28 days: · Day 1 - part of your first dose (100 mg) · Day 2 or Day 1 (continued) - remainder of first dose 900 mg · Day 8 - full dose (1,000 mg) · Day 15 - full dose (1,000 mg)
Øvre luftvejsinfektion, sinusitis§, urinvejsinfektion, lungebetændelse§, herpes zoster§
Upper respiratory tract infection, sinusitis§, , urinary tract infection, pneumonia§ ,herpes zoster§
• Du skal bruge sikker prævention mens du er i behandling med Gazyvaro
· Use an effective method of contraception while being treated with Gazyvaro.
Alle patienter bør screenes for hepatitis B, inden behandling med Gazyvaro påbegyndes.
HBVscreening should be performed in all patients before initiation of treatment with Gazyvaro.
• Progressiv multifokal leukoencefalopati er en meget sjælden, men livstruende hjernebetændelse, der er set hos meget få patienter, der har fået Gazyvaro.
· PML is a very rare and life-threatening brain infection that has been reported in very few patients having treatment with Gazyvaro.
Forekomsten af grad 3-4 infusionsrelaterede reaktioner (som forekom hos relativt få patienter) var den samme, før og efter tiltagene for at dæmpe infusionsrelaterede reaktioner blev indført.
The rates of Grade 3-4 IRRs (which occurred in relatively few patients) were similar before and after mitigation measures were implemented.
I ikke-kliniske studier inducerer obinutuzumab direkte celledød og medierer antistofafhængig, cellulær cytotoksicitet og antistofafhængig cellulær fagocytose ved rekruttering af FcɣRIII-positive immuneffektor-celler.
In nonclinical studies, obinutuzumab induces direct cell death and mediates antibody dependent cellular cytotoxicity (ADCC) and antibody dependent cellular phagocytosis (ADCP) through recruitment of FcɣRIII positive immune effector cells.
Gazyvaro er i kombination med chlorambucil indiceret til behandling af voksne patienter med tidligere ubehandlet kronisk lymfatisk leukæmi (CLL) og med co-morbiditet, der gør dem uegnede til fludarabinbaseret behandling i fuld dosis (se pkt.
Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated CLL and with comorbidities making them unsuitable for full-dose fludarabine based therapy (see section 5.1).
Fortæl det til lægen eller sundhedspersonalet hvis du oplever nogen af de nævnte bivirkninger.
Tell your doctor or nurse if you notice any of the side effects listed above.
Yderligere var der ingen umiddelbare virkninger af bendamustin, FC-kemoterapi, chlorambucil eller CHOP-kemoterapi på Gazyvaros farmakokinetik.
In addition, there were no apparent effects of bendamustine, FC, chlorambucil or CHOP on the pharmacokinetics of Gazyvaro.
Diarré, forstoppelse§
Diarrhoea, constipation§
Hæmoragiske bivirkninger og grad 3-5 hæmoragiske bivirkninger forekom hos hhv. 12 % og 5 % af patienterne.
Haemorrhagic events and Grade 3-5 haemorrhagic events occurred in 12% and 5% of patients, respectively.
Inden hver infusion af Gazyvaro, vil du få medicin, der mindsker risikoen for infusionsrelaterede reaktioner og for tumorlysesyndrom.
Before each infusion of Gazyvaro, you will be given medicines to lessen the chance of getting infusion related reactions or tumour lysis syndrome.
Gazyvaro er i kombination med kemoterapi efterfulgt af Gazyvaro-vedligeholdelsesbehandling hos patienter, som opnåede respons, indiceret til behandling af patienter med tidligere ubehandlet, fremskreden follikulært lymfom (FL) (se pkt.
Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced FL (see section 5.1)
Chlorambucil blev givet oralt, 0,5 mg/kg kropsvægt, på 1. dag og 15. dag i alle behandlingsserierne
1 Chlorambucil is given orally at 0.5 mg/kg body weight on Day 1 and Day 15 of all treatment cycles
Risikoreduktionen for sygdoms-progression eller død, som ses hos patienter med indolent non-Hodgkin lymfom, er drevet af subgruppen af patienter med follikulært lymfom.
The reduction in the risk of disease progression or death seen in the iNHL population is driven by the subset of patients with FL.
Der er udført begrænsede sub-studier for lægemiddelinteraktion mellem Gazyvaro og bendamustin, CHOP-kemoterapi, fludarabin, cyclophospamid (FC-kemoterapi) og chlorambucil.
No formal drug-drug interaction studies have been performed, although limited drug-drug interaction sub-studies have been undertaken for Gazyvaro with bendamustine, CHOP, fludarabine and cyclophosphamide (FC), and chlorambucil.
18,7 måneders medianobservationstidg
18.7 months median observation time g
R-Kemo: Rituximab plus kemoterapi, G-Kemo: Gazyvaro plus kemoterapi
R-Chemo: Rituximab plus chemotherapy, G-Chemo: Gazyvaro plus chemotherapy, HR: hazard ratio, CI: confidence interval
På grund af produktets farmakologiske egenskaber er B-celledepletering forventelig hos spædbørn, der har været eksponeret under graviditeten.
In case of exposure during pregnancy, depletion of B-cells may be expected in infants due to the pharmacological properties of the product.
0,50, 1,20), CVP (n = 118): hazard ratio 0,63 (95% konfidensinterval: 0,32, 1,21), og bendamustin (n = 686): hazard ratio 0,61 (95 % konfidensinterval: 0,43, 0,86).
The observed HRs by chemotherapy subgroup were as follows; CHOP (n = 398): HR 0.77 (95% CI: 0.50, 1.20), CVP (n = 118): HR 0.63 (95% CI: 0.32, 1.21), and bendamustine (n = 686): HR 0.61 (95% CI: 0.43, 0.86).
Fertile kvinder skal anvende sikker prævention under behandling og i 18 måneder efter behandling med Gazyvaro.
Women of childbearing potential must use effective contraception during and for 18 months after treatment with Gazyvaro.
Kun den højeste observerede frekvens i de kliniske forsøg er rapportet (baseret på studie BO21004/ tidligere ubehandlet kronisk lymfatisk leukæmi, BO21223/tidligere ubehandlet fremskreden indolent non-Hodgkin lymfom og GAO4753g/rituximab refraktær indolent non-Hodgkin lymfom).
Only the highest frequency observed in the trials is reported (based on studies BO21004/previously untreated CLL, BO21223/previously untreated advanced iNHL and GAO4753g/rituximab refractory iNHL)
Når symptomerne er forsvundet, og hvis patienten ikke oplever symptomer på infusionsrelaterede reaktioner, kan infusionshastigheden fortsætte med de trinvise øgninger og intervaller, der gælder for denne dosis (se tabel 4 og 5).
Infusion can be continued upon resolution of symptoms and, if the patient does not experience any IRR symptoms, the infusion rate escalation can resume at the increments and intervals as appropriate for the treatment dose (see Tables 4 and 5).
Der er også indberettet tilfælde af forlænget neutropeni (2% i Gazyvaro plus chlorambucil-armen og 4% i rituximab plus chlorambucil-armen) og sent forekommende neutropeni (16% i Gazyvaro plus chlorambucil-arm og 12% i rituximab plus chlorambucil-armen) (se pkt.
Cases of prolonged neutropenia (2% in the Gazyvaro plus chlorambucil arm and 4% in the rituximab plus chlorambucil arm) and late onset neutropenia (16% in the Gazyvaro plus chlorambucil arm and 12% in the rituximab plus chlorambucil arm) were also reported (see section 4.4).
Pædiatrisk population Der er ikke gennemført studier vedrørende obinutuzumabs farmakokinetik hos pædiatriske patienter.
No studies have been conducted to investigate the pharmacokinetics of obinutuzumab in paediatric patients.
Effektresultaterne hos patienter med tidligere ubehandlet kronisk lymfatisk leukæmi er opsummeret i tabel 7.
Efficacy results for patients with previously untreated CLL are summarised in Table 7.
Obinutuzumab, som er glycoengineered antistof, er karakteriseret ved forstærket antistofafhængig cellulær cytotoksicitet og fagocytose sammenlignet med de non-glycoengineered antistoffer i ækvivalent dosis.
Obinutuzumab, as a glycoengineered antibody, is characterised by enhanced ADCC and ADCP compared to non-glycoengineered antibodies at an equivalent dose.
Vaccination med levende virusvacciner bør udsættes hos spædbørn, hvis mødre er behandlet med obinutuzumab under graviditeten indtil spædbarnets B-celletal er inden for normalområdet (se pkt.
Postponing vaccination with live vaccines should be considered for infants born to mothers who have been exposed to Gazyvaro during pregnancy until the infant's B-cell levels are within normal ranges (see section 4.4).
Infusionsrelaterede reaktioner kan være svære 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).
Obinutuzumab, et Type II-antistof, sammenlignet med Type I antistoffer i ækvivalent dosis, er karakteriseret ved øget induktion af direkte celledød med samtidig reduktion af komplementafhængig cytotoksicitet.
Compared to Type I antibodies, obinutuzumab, a Type II antibody, is characterised by an enhanced direct cell death induction with a concomitant reduction in CDC at an equivalent dose.
Clearance af obinutuzumab var ca. 0,11 l/dag hos patienter med kronisk lymfatisk leukæmi og 0,08 l/dag hos patienter med indolent non-Hodgkin lymfom med en median halveringstid på 26,4 dage hos patienter med kronisk lymfatisk leukæmi og 36,8 dage hos patienter med indolent non-Hodgkin lymfom.
The clearance of obinutuzumab was approximately 0.11 L/day in CLL patients and 0.08 L/day in iNHL patients with a median elimination t½ of 26.4 days in CLL patients and 36.8 days in iNHL patients.
fx 1000 mg paracetamol 3 fx 50 mg diphenhydramin
3 e.g. 50 mg diphenhydramine
Disse patienter oplevede flere alvorlige bivirkninger, dødelige bivirkninger og bivirkninger som førte til seponering end patienter med CrCl ≥ 50 ml/min (se pkt.
These patients experienced more serious adverse events, adverse events leading to death and adverse events leading to treatment withdrawal than patients with a CrCl ≥ 50 mL/min (see section 4.2 and 5.2).
Dyspepsi, colitis, hæmorider
Dyspepsia, colitis, haemorrhoids Diarrhoea, colitis
Tabel 7 Resumé af effektresultater i studie BO21004/CLL11
Table 7 Summary of efficacy from BO21004/CLL11 study Stage 1a
Der er ikke etableret klar sammenhæng mellem trombocytopeni og hæmorrhagiske bivirkninger.
A clear relationship between thrombocytopenia and haemorrhagic events has not been established.
I alt blev seks behandlingsserier med Gazyvaro (hver 28. dag) givet i kombination med seks behandlingsserier af bendamustin, og i alt otte behandlingsserier af Gazyvaro (hver 21. dag) blev givet i kombination med seks behandlingsserier af CHOP eller otte behandlingsserier af CVP.
In total, six cycles of Gazyvaro (every 28 days) were given in combination with six cycles of bendamustine, and a total of eight cycles of Gazyvaro (every 21 days) were given in combination with six cycles of CHOP or eight cycles of CVP.
Den farmakokinetiske populationsanalyse af obinutuzumab viste, at alder ikke påvirker obinutuzumabs farmakokinetik.
The population pharmacokinetic analysis of obinutuzumab showed that age did not affect the pharmacokinetics of obinutuzumab.
Infusionshastighed
Rate of infusion
Brug af anden medicin sammen med Gazyvaro
Other medicines and Gazyvaro
• Hvis du bliver gravid under din behandling med Gazyvaro, skal du kontakte lægen eller sundhedspersonalet hurtigst muligt, da behandling med Gazyvaro kan påvirke dit og barnets helbred.
· If you become pregnant during treatment with Gazyvaro, tell your doctor or nurse as soon as possible.
Der kan, som et symptom på infusionsrelaterede reaktioner, opstå hypotension under intravenøs infusion af Gazyvaro.
Hypotension, as a symptom of IRRs, may occur during Gazyvaro intravenous infusions.
Patienter med follikulært lymfom, som ikke responderede eller som fik sygdomsprogression under eller op til 6 måneder efter behandling med rituximab eller en behandling indeholdende rituximab (studie GAO4753g/GADOLIN)
Patients with follicular lymphoma who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen (study GAO4753g/GADOLIN).
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 <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 < 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 <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 < 50 mL/min).
Bivirkningsprofilen hos patienter med follikulært lymfom var i overensstemmelse med bivirkningsprofilen hos den samlede population med indolent non-Hodgkin lymfom i begge studier.
The profile of adverse reactions in patients with FL was consistent with the overall iNHL population in both studies.
Der er set svær og livstruende trombocytopeni, inklusive akut trombocytopeni (opstået inden for 24 timer efter infusionen) ved behandling med Gazyvaro.
Severe and life-threatening thrombocytopenia including acute thrombocytopenia (occurring within 24 hours after the infusion) has been observed during treatment with Gazyvaro.
Ialt oplevede 7% af patienterne en infusionsrelateret reaktion, der medførte seponering af Gazyvaro.
Overall, 7% of patients experienced an IRR leading to discontinuation of Gazyvaro.
Patienter med CrCl <30 ml/min blev ekskluderet fra studiet (se pkt.
Patients with a CrCl < 30 mL/min were excluded from the study (see section 5.1).
Hvad er Gazyvaro?
What Gazyvaro is
Der er indberettet tilfælde af gastrointestinal perforation hos patienter behandlet med Gazyvaro, hovedsageligt hos patienter med indolent non-Hodgkin lymfom.
Cases of gastro-intestinal perforation have been reported in patients receiving Gazyvaro, mainly in iNHL.
Behandling med Gazyvaro bør afbrydes under udredning af eventuel progressiv multifokal leukoencefalopati og permanent seponeres, hvis progressiv multifokal leukoencefalopati bekræftes.
Therapy with Gazyvaro should be withheld during the investigation of potential PML and permanently discontinued in case of confirmed PML.
I gruppen af ikke-follikulært lymfom patienter var hazard ratio for progressionsfri overlevelse, vurderet af en uafhængig komité, 0,94 (95% konfidensinterval, 0,49; 1,90).
In the non-FL population the HR for IRC-assessed PFS was 0.94 [95% CI: 0.49, 1.90].
Almindelig nattesved, eksem
Night sweats, eczema
Luftveje, thorax og mediastinum Meget almindelig
Respiratory, thoracic and mediastinal disorders Very common
Indberettet mindre ofte: uregelmæssigt hjerteslag (puls) hævelse af svælg eller luftveje hvæsende vejrtrækning, vejrtrækningsbesvær, trykken for brystet eller irritation i svælget
Less frequently reported: · irregular heartbeat · swelling of the throat or airway · wheezing, difficulty breathing, tight chest or throat irritation
Hazard ratio (95% konfidensinterval) p-værdi (stratificeret log-rank testb)
Hazard ratio (95% CI) p-value (Log-Rank test, stratified b)
Den anbefalede dosis af Gazyvaro i kombination med chlorambucil er 1000 mg administreret på 1. og 2. dag (eller fortsat på 1. dag), 8. dag og 15. dag i den første 28-dages behandlingsserie.
The recommended dose of Gazyvaro in combination with chlorambucil is 1,000 mg administered over Day 1 and Day 2 (or Day 1 continued), and on Day 8 and Day 15 of the first 28 day treatment cycle.
Oralt analgetikum/antipyretikum2
Oral analgesic/anti-pyretic2
Indlægsseddel: Information til patienten Gazyvaro 1000 mg koncentrat til opløsning til infusion obinutuzumab
Package leaflet: Information for the patient Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab
Det bør derfor overvejes at standse antihypertensiv behandling i 12 timer inden og under hver infusion af Gazyvaro samt i en time efter administration (se pkt.
Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each Gazyvaro infusion and for the first hour after administration (see section 4.4).
Tumorlysesyndrom, hyperuricæmi, hypokaliæmi
Tumour lysis syndrome, hyperuricaemia, hypokalaemia
Urinvejsinfektion, lungebetændelse, lungeinfektion, øvre luftvejsinfektion, sinusitis, herpes zoster
Urinary tract infection, pneumonia, lung infection, upper respiratory tract infection, sinusitis, herpes zoster
Patienter med CrCl <40 ml/min blev ekskluderet fra studierne (se pkt.
Patients with a CrCl < 40 mL/min were excluded from the studies (see section 5.1).
Farmakokinetiske/farmakodynamiske-forhold
Pharmacokinetic/pharmacodynamic relationship(s)
I det pivotale studie, BO21004/CLL11 var 46% (156 ud af 336) af patienterne med kronisk lymfatisk leukæmi, der blev behandlet med Gazyvaro plus chlorambucil 75 år eller derover (medianalder var 74 år).
In the pivotal BO21004/CLL11 study, 46% (156 out of 336) of patients with CLL treated with Gazyvaro plus chlorambucil were 75 years or older (median age was 74 years).
Tabel 2 Gazyvaro-dosis der skal administreres i 6 behandlingsserier, hver af 28 dages varighed hos patienter med kronisk lymfatisk leukæmi
Table 2 Dose of Gazyvaro to be administered during 6 treatment cycles each of 28 days duration for patients with CLL
• urinvejsinfektion, næse og svælg inflammation, helvedesild ændringer i blodprøve-resultater: - blodmangel (lavt antal af røde blodlegemer ) - lavt antal af lle typer hvide blodlegmer (kombineret) - lavt antal af neutrofilocytter (en type hvide blodlegemer) - lavt antal af blodplader (som hjælper blodet med at størkne) infektion i de øvre luftveje (næse, svælg, strube og bihuler), hoste
· changes in blood tests: anaemia (low levels of red blood cells) low levels of all types of white blood cell (combined) low levels of neutrophils (a type of white blood cell) low level of platelets (a type of blood cell that helps your blood to clot)
Andre fortyndingsmidler, fx glucose (5%) injektionsvæske må ikke bruges.
Do not use other diluents such as glucose (5%) solution.
4.2 og 5.2).
NR (22.5,-)
1. dag (100 mg)
Day 1 (100 mg)
Præmedicinering med kortikosteroider i den første behandlingsserie anbefales til patienter med follikulært lymfom og er obligatorisk til patienter med kronisk lymfatisk leukæmi (se tabel 1).
Corticosteroid premedication is recommended for patients with FL and mandatory for CLL patients in the first cycle (see Table 1).
Pakningsstørrelse med 1 hætteglas
Pack size of 1 vial.
Kontakt straks lægen eller sundhedspersonalet, hvis du under og efter en behandling med Gazyvaro oplever tegn på infektion.
Tell your doctor or nurse straight away if you get any signs of infection during and after your Gazyvaro treatment.
Bendamustin blev administreret intravenøst på dag 1 og 2 for alle behandlingsserier (behandlingsserier 1-6) ved 90 mg/m2/dag, når administreret i kombination med Gazyvaro.
Bendamustine was given intravenously on Days 1 and 2 for all treatment cycles (Cycles 1-6) at 90 mg/m2/day when given in combination with Gazyvaro.
Hvad bruges Gazyvaro til?
What Gazyvaro is used for
Bendamustin blev givet intravenøst på dag 1og 2 for alle behandlingsserier (serie 1-6) i en dosis på 90 mg/m2/dag, når det blev indgivet i kombination med Gazyvaro, og i en dosis på 120 mg/m2/dag, når det blev indgivet alene.
Bendamustine was given intravenously on Days 1 and 2 for all treatment cycles (Cycles 1-6) at 90 mg/m2/day when given in combination with Gazyvaro or 120 mg/m2/day when given alone.
Trombocytopeni, der opstod under eller 24 timer efter endt infusion (akut trombocytopeni) blev observeret hyppigere hos patienter i Gazyvaro plus kemoterapi-armen end i komparator-armen.
Thrombocytopenia occurred more frequently in Cycle 1 in the Gazyvaro plus chemotherapy arm. Thrombocytopenia occurring during or 24 hours from end of infusion (acute thrombocytopenia) was more frequently observed in patients in the Gazyvaro plus chemotherapy arm than in the comparator arm.
• hul i mavesækken eller tarmene (gastrointestinal perforation.
● a hole in the stomach or intestines (gastrointestinal perforation, especially in cases where the cancer affects the gastrointestinal tubes)
Gazyvaro + Kemoterapi efterfulgt af Gazyvaro vedligeholdelsesbehandling N=601
Gazyvaro +Chemotherapy followed by Gazyvaro maintenance N=601
Incidensen af infusionsrelaterede reaktioner var højere i Gazyvaro plus chlorambucil-armen end i rituximab plus chlorambucil-armen.
The incidence of IRRs was higher in the Gazyvaro plus chlorambucil arm compared to the rituximab plus chlorambucil arm.
Meget almindelige (kan påvirke mere end 1 ud af 10 patienter) feber lungeinfektion hovedpine ledsmerter, smerter i ryg svaghedsfølelse diarré, forstoppelse
Very common (may affect more than 1 in 10 people) · fever · lung infection · headache · joint pain, back pain · feeling weak · diarrhoea, constipation · sleeplessness · hair loss, itchiness · urinary tract infection, nose and throat inflammation, shingles
Overfølsomhedsreaktioner med hurtig (fx anafylaksi) og sen (fx serum-syge) indtræden er rapporteret hos patienter behandlet med Gazyvaro.
Hypersensitivity reactions with immediate (e.g. anaphylaxis) and delayed onset (e.g. serum sickness) have been reported in patients treated with Gazyvaro.
Reaktivering af hepatitis B Der er indberettet tilfælde af reaktivering af hepatitis B hos patienter behandlet med Gazyvaro (se pkt.
Cases of hepatitis B reactivation have been reported in patients treated with Gazyvaro (see section 4.4).
Induktionsbehandling på omkring seks måneder (seks behandlingsserier med Gazyvaro, hver af 28 dages varighed i kombination med bendamustin, eller otte behandlingsserier med Gazyvaro, hver af 21 dages varighed i kombination med CHOP eller CVP) efterfulgt af vedligeholdelsesbehandling én gang hver 2. måned i 2 år eller indtil sygdomsprogression (hvad end, der opstår først).
Induction treatment of approximately six months (six treatment cycles of Gazyvaro, each of 28 day duration when combined with bendamustine, or eight treatment cycles of Gazyvaro, each of 21 day duration when combined with CHOP or CVP) followed by maintenance once every 2 months for 2 years or until disease progression (whichever occurs first).
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 > 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)