natgillin/translations-raw huggingface dataset:
Primært endepunkt Progressionsfri overlevelse vurderet af en uafhængig komité Antal (%) patienter med hændelse Median tid til hændelse (måneder, 95% konfidensinterval)
Primary Endpoint in FL population IRC-assessed PFS (PFS-IRC) Number (%) of patients with event Median time to event (months, 95% CI)
Gazyvaro-dosis, der skal gives
Dose of Gazyvaro to be administered
Andre fortyndingsmidler, fx glucose (5%) injektionsvæske må ikke bruges (se pkt.
Do not use other diluents such as glucose (5%) solution (see section 6.2).
Alle grader Gazyvaro + kemoterapi* (kronisk lymfatisk leukæmi, indolent non-Hodgkin lymfom) efterfulgt af Gazyvarovedligeholdelsesbehandling (indolent non-Hodgkin lymfom)
All Grades Gazyvaro + chemotherapy* (CLL, iNHL) followed by Gazyvaro maintenance (iNHL)
Hos patienter med kronisk lymfatisk leukæmi er den anbefalede dosis af Gazyvaro i kombination med chlorambucil angivet i tabel 2.
For patients with CLL the recommended dose of Gazyvaro in combination with chlorambucil is shown in Table 2.
• Du vil få 6 behandlingsserier med Gazyvaro i kombination med chlorambucil, et andet lægemiddel mod kræft.
Chronic lymphocytic leukaemia · You will be given 6 treatment cycles of Gazyvaro in combination with another medicine for cancer called chlorambucil.
Der er i toksicitetsstudier med gentagne doser til cynomolgusaber ikke set negativ påvirkning af de mandlige eller kvindelige forplantningsorganer (se pkt.
No adverse effects on male and female reproductive organs were observed in repeat-dose toxicity studies in cynomolgus monkeys (see section 5.3).
• Otte 21-dages behandlingsserier i kombination med cyclophosphamid, vincristin og prednison/prednisolon/methylprednisolon (CVP).
· Six 21-day cycles in combination with cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP), followed by 2 additional cycles of Gazyvaro alone or · Eight 21-day cycles in combination with cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone (CVP).
Afkommets Bcelletal og immunologiske funktion normaliseredes inden for 6 måneder efter fødslen.
B-cell counts returned to normal levels in the offspring, and immunologic function was restored within 6 months of birth.
Profylakse og præmedicinering for tumorlysesyndrom Patienter med høj tumorbyrde og/eller højt antal cirkulerende lymfocytter (>25 x 109/l) og/eller nedsat nyrefunktion (CrCl <70 ml/min) er anset for at være i risiko for tumorlysesyndrom og bør have profylaktisk behandling.
Patients with a high tumour burden and/or a high circulating lymphocyte count (> 25 x 109/L) and/or renal impairment (CrCl < 70 mL/min) are considered at risk of TLS and should receive prophylaxis.
Indolent non-Hodgkin lymfom inklusive follikulært lymfom I de pivotale studier (BO21223/GALLIUM og GAO4753g/GADOLIN) med indolent non-Hodgkin lymfom oplevede patienter, som var 65 år eller derover mere alvorlige bivirkninger og bivirkninger medførende seponering eller død end patienter <65 år.
In the pivotal studies (BO21223/GALLIUM, GAO4753g/GADOLIN) in iNHL, patients 65 years or older experienced more serious adverse events and adverse events leading to withdrawal or death than patients < 65 years of age.
Profylakse bør bestå af tilstrækkelig hydrering og administration af uratsænkende middel (fx allopurinol) eller anden passende alternativ behandling, som fx uratoxidase (fx rasburikase), indledt 12-24 timer inden infusion af Gazyvaro i henhold til standardpraksis.
Prophylaxis should consist of adequate hydration and administration of uricostatics (e.g. allopurinol), or suitable alternative such as a urate oxidase (e.g. rasburicase) starting 12-24 hours prior to start of Gazyvaro infusion as per standard practice.
Patienter med nedsat nyrefunktion (CrCl <50 ml/min) og patienter med en en co-morbiditetsscore >6 på CIRS-skalaen (Cumulative Illness Rating Scale) samt CrCl <70 ml/min har højere risiko for infusionsrelaterede reaktioner, inklusive svære infusionsrelaterede reaktioner (se pkt.
Patients with renal impairment (CrCl < 50 mL/min) and patients with both Cumulative Illness Rating Scale (CIRS) > 6 and CrCl < 70 mL/min are more at risk of IRRs, including severe IRRs (see section 4.8).
22 månedersmedian observationstid
Median observation time: 22 months
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
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
Tumorlysesyndrom, hypokaliæmi
Tumour lysis syndrome, hypokalaemia
Profylakse bør bestå af tilstrækkelig hydrering og administration af uratsænkende middel (fx allopurinol) eller anden passende alternativ behandling, som fx uratoxidase (fx rasburikase), indledt 12-24 timer inden Gazyvaro infusion i henhold til standardpraksis (se pkt.
Prophylaxis should consist of adequate hydration and administration of uricostatics (e.g. allopurinol), or suitable alternative treatment such as urate oxidase (e.g. rasburicase), starting 12-24 hours prior to start of Gazyvaro infusion as per standard practice (see section 4.4).
Vigtigste sekundære endepunkter Uafhængig komité-vurderet progressionfri overlevelsea Antal (%) patienter med hændelse Median tid til hændelse (måneder) Hazard ratio (95% konfidensinterval) p-værdi (stratificeret log-rank testb) Responsrate ved behandlingsafslutning Antal patienter inkluderet i analysen Respondere (%) Non-respondere (%) Forskel i responsrate, (95% konfidensinterval) p-værdi (Chi-i anden-test) Antal patienter med fuldstændigt responsc (%) Molekylær remission ved behandlingsafslutning Antal patienter inkluderet i analysen MRD-negative (%) MRD-positiv f
Primary endpoint Investigator-assessed PFS (PFS-INV)a Number (%) of patients with event Median time to event (months) Hazard ratio (95% CI) p-value (Log-Rank test, stratifiedb) Key secondary endpoints IRC-assessed PFS (PFS-IRC)a Number (%) of patients with event Median time to event (months) Hazard ratio (95% CI) p-value (Log-Rank test, stratifiedb) End of treatment response rate No. of patients included in the analysis Responders (%) Non-responders (%) Difference in response rate, (95% CI) p-value (Chi-squared Test) No. of complete responders c
Af hensyn til miljøet må du ikke smide medicinrester i afløbet eller i skraldespanden.
Medicines should not be disposed of via wastewater or household waste.
1. dag (1000 mg)
Day 1 (1,000 mg)
Hvis patienten har oplevet en infusionsrelateret reaktion i den forudgående infusion, start med administration på 25 mg/time.
If the patient experienced an IRR during the previous infusion, start with administration at 25 mg/hr.
Forebyggende tiltag til reduktion af infusionsrelaterede reaktioner bør initieres (se pkt.
Mitigation measures to reduce IRRs should be followed (see section 4.2).
Nedenstående analyse af bivirkninger er derfor blevet udført på hele studiepopulationen (dvs. indolent non-Hodgkin lymfom) for at give den mest omfattende information om sikkerheden.
Therefore, in order to provide the most comprehensive safety information, the analysis of ADRs presented in the following has been performed on the entire study population (i.e. iNHL).
Tabel 8 Resumé af effektresultater hos patienter med tidligere ubehandlet follikulært lymfom i BO21223 (GALLIUM) studiet Rituximab + Kemoterapi efterfulgt af rituximab vedligeholdelsesbehandling N=601
Table 8 Summary of efficacy in patients with previously untreated FL from BO21223/ GALLIUM study
Hver serie varer 28 eller 21 dage afhængigt af hvilke andre lægemidler mod kræft, der gives sammen med Gazyvaro.
· You will be given 6 or 8 treatment cycles of Gazyvaro in combination with other medicines for cancer - each cycle lasts 28 or 21 days depending on which other cancer medicines are given together with Gazyvaro.
Patienter, der opnår et komplet eller partielt respons på induktionsbehandling med Gazyvaro i kombination med kemoterapi (CHOP, CVP eller bendamustin), skal fortsætte vedligeholdelsesbehandling med Gazyvaro 1000 mg som monoterapi én gang hver 2. måned i 2 år eller indtil sygdomsprogression (hvad end, der opstår først).
Patients who achieve a complete or partial response to induction treatment with Gazyvaro in combination with chemotherapy (CHOP or CVP or bendamustine) should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first).
For patienter med kronisk lymfatisk leukæmi, som får 1. dags (1. behandlingsserie) dosis over 2 dage, kan infusionshastigheden på 1. dag øges til 25 mg/time efter 1 time, men må ikke øges yderligere.
For CLL patients receiving the Day 1 (Cycle 1) dose split over two days, the Day 1 infusion rate may be increased back up to 25 mg/hr after 1 hour, but not increased further.
Gazyvaro-dosis
Dose of Gazyvaro
Kronisk lymfatisk leukæmi Tabel 4 Kronisk lymfatisk leukæmi: Standard-infusionshastigheder hvis der ikke ses infusionsrelaterede reaktioner/overfølsomhed og anbefalinger i tilfælde af infusionsrelaterede reaktioner opstået under forudgående infusion
Chronic Lymphocytic Leukaemia Table 4 Chronic lymphocytic leukaemia: Standard infusion rate in the absence of IRRs/hypersensitivity and recommendations in case an IRR occurred with previous infusion
I 1. behandlingsserie var den overordnede incidens af infusionsrelaterede reaktioner højere hos patienter, der fik Gazyvaro plus kemoterapi sammenlignet med patienter i komparator armenHos patienter, der fik Gazyvaro plus kemoterapi, var incidensen af infusionsrelaterede reaktioner højst på 1. behandlingsdag og faldt gradvist med efterfølgende infusioner.
In patients receiving Gazyvaro plus chemotherapy, the incidence of IRRs was highest on Day 1 and gradually decreased with subsequent infusions.
Serie
Cycle
2.- 6. eller 2.- 8. serie
Cycles 2-6 or
Almindelige (kan påvirke op til 1 ud af 10 patienter) røde øjne forkølelsessår depression, angst nattesved influenza vægtøgning smerter i lymfeknuder løbende eller stoppet næse eksem betændelseslignende tilstand (inflammation) i næsen eller svælget smerter i mund eller svælg muskel- og knoglesmerter i brystet hudkræft (planocellulært karcinom i huden) knogler, arme og ben uregelmæssige hjerteslag (atrieflimren), hjertesvigt problemer med vandladningen, urininkontinens forhøjet blodtryk problemer med fordøjelsen (fx halsbrand eller sure opstød), betændelse i tarmene, hæmorider ændringer i blodprøve-resultater: - lavt antal af lymfocytter (en type hvide blodlegemer) - forhøjet niveau af kalium, fosfat eller urinsyre, som kan give nyreproblemer (del af tumorlyse-syndrom) reduceret niveau af kalium
Talk to your doctor or nurse before you are given Gazyvaro if: · you have an infection, or have had an infection in the past which lasted a long time or keeps coming back · you have ever taken, or been given, medicines which affect your immune system (such as chemotherapy or immunosuppressants) · you are taking medicines for high blood pressure or medicines used to thin your blood - your doctor might need to alter how you take these · you have ever had heart problems · you have ever had brain problems (such as memory problems, difficulty moving or feeling sensations in your body, eyesight problems) · you have ever had breathing problems or lung problems · you have ever had “hepatitis B” - a type of liver disease · you are due to have a vaccine or you know you may need to have one in the near future.
(komplet respons/partielt respons) Forskel i responsrate (%)(95% konfidensinterval) p-værdi
(INV-assessed, CT) Responders (%) (CR, PR) Difference in response rate (%) [95% CI] p-value (Cochran-Mantel-Haenszel test) Complete Response (CR) Partial Response (PR)
Patienter, som opnåede et komplet eller partiel respons på induktionsbehandlingen (dvs. de initiale 6 behandlingsserier) med Gazyvaro i kombination med bendamustin eller som har stabil sygdom, skal fortsætte i vedligeholdelsesbehandling med Gazyvaro 1000 mg som monoterapi én gang hver 2. måned i 2 år eller indtil sygdomsprogression (hvad end der opstår først).
Patients who achieved a complete or partial response to induction treatment (i.e. the initial 6 treatment cycles) with Gazyvaro in combination with bendamustine or have stable disease should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first).
Dag i behandlingsserien
Day of treatment cycle
• smertefuldt udslæt
Hepatic impairment
Nasofaryngitis, rinitis, influenza, oral herpes Benigne, maligne og uspecificerede tumorer (inkl.
Nasopharyngitis, rhinitis, influenza, oral herpes
Planocellulært carcinom i huden Planocellulært carcinom i huden
Squamous cell carcinoma of skin Squamous cell carcinoma of skin Blood and lymphatic system disorders Very common
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use For intravenous use after dilution Do not shake the vial
Hvis ingen infusionsrelateret reaktion opstod under den forudgående infusion, gives 50 mg/time.
If no IRR occurred during the previous infusion, administer at 50 mg/hr.
Patienter som opnåede et komplet eller partielt respons på induktionsbehandling med Gazyvaro i kombination med kemoterapi skal fortsætte i vedligeholdelsesbehandling med Gazyvaro 1000 mg som monoterapi én gang hver 2. måned i 2 år eller indtil sygdomsprogression (hvad end, der opstår først).
Patients who achieve a complete or partial response to induction treatment with Gazyvaro in combination with chemotherapy should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first).
# 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
# Patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen
Kaplan-Meier-kurve over samlet overlevelse hos patienter med follikulært lymfom# (GAO4753g /GADOLIN-studiet)
Figure 7 Kaplan-Meier curve of OS in patients with FL # (Study GAO4753g/GADOLIN)
LÆGEMIDLETS NAVN Gazyvaro 1000 mg koncentrat til infusionsvæske, opløsning
NAME OF THE MEDICINAL PRODUCT Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab
Nyre og urinveje Almindelige
Renal and Urinary Disorders Common
Hazard ratio (95% konfidensinterval) p-værdi (stratificeret log-rank test,*) Sekundære endepunkter Investigator-vurderet progressionsfri overlevelse Antal (%) patienter med hændelse Median til til hændelse (måneder, 95% konfidensinterval) Hazard ratio (95% konfidensinterval) p-værdi (stratificeret log-rank test,*) Bedste samlede respons (vurderet af en uafhængig komité)§ Antal patienter inkluderet i analysen Respondere (%) (komplet respons/partielt respons) Forskel i responsrate (95% konfidensinterval) p-værdi (Cochran-Mantel-Haenszel test) Komplet respons (%) Partielt respons (%) Stabil sygdom (%) Responsvarighed (vurderet af en uafhængig komité) Antal patienter inkluderet i analysen Antal (%) patienter med hændelse Median (måneder) responsvarighed (95% konfidensinterval)
Best Overall Response (BOR) (IRC-assessed) No. of patients included in the analysis Responders (%) (CR/PR) Difference in response rate (95% CI) p-value (Cochran-Mantel-Haenszel test) Complete Responders (%) Partial Responders (%) Stable Disease (%) Duration of response (DOR) (IRCassessed) No of patients included in the analysis No. (%) of patients with event Median duration (months) of DOR (95% CI)
2.- 6. behandlingsserie ved kronisk lymfatisk leukæmi og alle behandlingsserier ved follikulært lymfom Træk 40 ml koncentrat op af hætteglasset og fortynd i polyvinylchlorid (PVC)- eller non-PVC polyolefininfusionspose indeholdende natriumchlorid 9 mg/ml (0,9%) opløsning til injektion.
Withdraw 40 mL of concentrate from the vial and dilute in polyvinyl chloride (PVC) or non-PVC polyolefin infusion bags containing sodium chloride 9 mg/mL (0.9%) solution for injection.
Gem indlægssedlen.
· Keep this leaflet.
Du vil få 100 mg Gazyvaro meget langsomt, mens lægen/sundhedspersonalet overvåger dig for infusionsrelaterede reaktioner.
Your doctor/nurse will monitor you carefully for infusion related reactions.
MRD-negativitet defineres som et resultat under 0,0001 f Inkluderer MRD-positive patienter og patienter, der har oplevet progression eller er døde inden behandlingen er afsluttet gMedian observationstid for samlet overlevelse svarer til 62,5 måneders median observationstid i stadie 1a og til 59,4 måneders median observationstid i stadie 2
IRC: Independent Review Committee; PFS: progression-free survival; HR: Hazard Ratio; CI: Confidence Intervals, MRD: Minimal Residual Disease, NR = Not reached a Defined as the time from randomisation to the first occurrence of progression, relapse or death from any cause as assessed by the investigator b stratified by Binet stage at baseline c Includes 11 patients in the GClb arm with a complete response with incomplete marrow recovery d Blood and bone marrow combined e MRD negativity is defined as a result below 0.0001 f Includes MRD positive patients and patients who progressed or died before the end of treatment g Median observation time for overall survival (OS) data corresponds to 62.5 months median observation time in Stage 1a and to 59.4 months median observation time in Stage 2.
Artralgi, rygsmerter, muskuloskeletale brystsmerter, knoglesmerter
Arthralgia, back pain, musculoskeletal chest pain, bone pain
Denne subgruppe omfattede 21% (253/1202) af follikulært lymfom intention-to-treat-populationen og udgjorde 16,3 % (40/245) af progressionsfri overlevelse tilfældene.Desuden var de eksplorative subgruppe analyser af progressionsfri overlevelse på tværs af kemoterapi behandlinger (bendamustin, CHOP og CVP) i overensstemmelse med resultaterne observeret i Gazyvaro plus kemoterapi populationen.
This subgroup comprised 21% (253/1202) of the FL ITT population and experienced 16.3% (40/245) of the PFS events.
• gentagelse af en grad 3infusionsrelateret reaktion (forlænget/recidiverende) (efter genoptagelse af første infusion eller under en efterfølgende infusion).
Patients must not receive further Gazyvaro infusions if they experience: · acute life-threatening respiratory symptoms, · a Grade 4 (i.e. life threatening) IRR or, · a second occurrence of a Grade 3 (prolonged/recurrent) IRR (after resuming the first infusion or during a subsequent infusion).
• Det aktive indholdsstof er obinutuzumab: 1000 mg/40 ml per hætteglas svarende til en koncentration på 25 mg/ml inden fortynding.
Contents of the pack and other information What Gazyvaro contains · The active substance is obinutuzumab: 1,000 mg/40 mL per vial corresponding to a concentration before dilution of 25 mg/mL.
Hvis ingen infusionsrelateret reaktion opstod under den forudgående infusion, da slut-infusionshastigheden var 100mg/time eller højere, kan infusion startes ved 100 mg/time og øges i trin af 100 mg/time hver 30. minut til maksimalt 400 mg/time.
If no IRR occurred during the previous infusion, when the final infusion rate was 100 mg/hr or faster, infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.
Hvordan virker Gazyvaro?
How Gazyvaro works
Hvis ingen infusionsrelateret reaktion eller en infusionsrelateret reaktion af grad 1 opstod under den forudgående infusion, da slut-infusionshastighed var 100 mg/time eller højere, kan infusion startes ved 100 mg/time og øges i trin af 100 mg/time hver 30. minut til maksimalt 400 mg/time.
If no IRR or if an IRR Grade 1 occurred during the previous infusion when the final infusion rate was 100 mg/hr or faster, infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.
6.6 for vejledning i fortynding af Gazyvaro inden brug.
For instructions on dilution of Gazyvaro before administration, see section 6.6.
Hoste, orofaryngeal smerte
Cough, oropharyngeal pain
Incidensen af neutropeni var højere i Gazyvaro plus chlorambucil-armen (41%) end i rituximab plus chlorambucil-armen.
The incidence of neutropenia was higher in the Gazyvaro plus chlorambucil arm (41%) compared to the rituximab plus chlorambucil arm with the neutropenia resolving spontaneously or with use of granulocyte-colony stimulating factors.
Alle efterfølgende infusioner gælder for kronisk lymfatisk leukæmi og follikulært lymfom
All subsequent infusions for CLL and FL
Fald i leukocytter, fald i neutrofilocytter, vægtøgning
White blood cell count decreased, neutrophil count decreased, weight increased
På grund af obinutuzumabs immunsupprimerende effekt frarådes vaccination med levende virusvacciner under behandling og indtil B-celleniveauet er normaliseret (se pkt.
Vaccination with live virus vaccines is not recommended during treatment and until B-cell recovery because of the immunosuppressive effect of obinutuzumab (see section 4.4).
Kaplan-Meier-kurve over samlet overlevelse fra stadie 1a hos patienter med kronisk lymfatisk leukæmi (studie BO21004/CLL11)
Figure 2 Kaplan-Meier curve of OS from Stage 1a in patients with CLL (Study BO21004/CLL11)
Kaplan-Meier-kurve over progressionsfri overlevelse, vurderet af en uafhængig komité, hos patienter med follikulært lymfom# (GAO4753g /GADOLIN-studiet)
Figure 6 Kaplan-Meier curve of IRC-assessed PFS in patients with FL # (Study GAO4753g/GADOLIN)
Kaplan-Meier-kurve over investigator-vurderet progressionsfri overlevelse fra stadie 1a hos patienter med kronisk lymfatisk leukæmi (studie BO21004/CLL11)
Figure 1 Kaplan-Meier curve of Investigator assessed PFS from Stage 1a in patients with CLL (Study BO21004/CLL11)
Tabel 5 Follikulært lymfom: Standard-infusionshastighed, hvis der ikke ses infusionsrelaterede reaktioner/overfølsomhed, samt anbefalinger i tilfælde af infusionsrelaterede reaktioner opstået under den forudgående infusion
Table 5 Follicular lymphoma: Standard infusion rate in the absence of IRRs /hypersensitivity and recommendations in case an IRR occurred with previous infusion
Behandlingsserie 2 -6
Cycles 2-6
Kaplan-Meier-kurve over investigator-vurderet progressionsfri overlevelse fra stadie 2 hos patienter med kronisk lymfatisk leukæmi (studie BO21004/CLL11)
Figure 3 Kaplan-Meier curve of investigator assessed PFS from Stage 2 in patients with CLL (Study BO21004/CLL11)
Atrieflimren, hjertesvigt
Atrial fibrillation, cardiac failure Atrial fibrillation, cardiac failure,
Kaplan-Meier-kurve over samlet overlevelse fra stadie 2 hos patienter med kronisk lymfatisk leukæmi (studie BO21004/CLL11)
Figure 4 Kaplan-Meier curve of OS from Stage 2 in patients with CLL (Study BO21004/CLL11)
Tabel 4 Kronisk lymfatisk leukæmi: Standard-infusionshastighed,hvis der ikke ses infusionsrelaterede reaktioner/overfølsomhed, samt anbefalinger i tilfælde af infusionsrelaterede reaktioner opstået under den forudgående infusion
Table 4 Chronic lymphocytic leukaemia: Standard infusion rate in the absence of IRRs/hypersensitivity and recommendations in case an IRR occurred with previous infusion
Gazyvaro + kemoterapi* (kronisk lymfatisk leukæmi, indolent non-Hodgkin lymfom)efterfulgt af Gazyvarovedligeholdelsesbehandling (indolent non-Hodgkin lymfom)
Grades 3-5† Gazyvaro + chemotherapy* (CLL, iNHL) followed by Gazyvaro maintenance (iNHL)
I disse studier blev Gazyvaro undersøgt i kombination med chlorambucil hos patienter med kronisk lymfatisk leukæmi og med bendamustin, CHOP eller CVP efterfulgt af Gazyvaro vedligeholdelsesbehandling hos patienter med indolent non-Hodgkin lymfom.. BO21223/GALLIUM og GAO4753g/GADOLINstudierne rekrutterede patienter med indolent non-Hodgkin lymfom herunder follikulært lymfom.
These trials investigated Gazyvaro in combination with chlorambucil for CLL and with bendamustine, CHOP or CVP followed by Gazyvaro maintenance therapy for iNHL.
Muskuloskeletale brystsmerter, ekstremitetssmerter, knoglesmerter
Musculoskeletal chest pain, pain in extremity, bone pain