natgillin/translations-raw huggingface dataset:
• tidligere har haft leverproblemer eller leversygdom, eller hvis du har symptomer på en alvorlig tilstand, der kaldes hepatisk veno-okklusiv sygdom, hvor blodkarrene i leveren bliver beskadiget og tilstoppet af blodpropper.
• have a history of liver problems or liver diseases or if you have signs and symptoms of a serious condition called hepatic venoocclusive disease, a condition in which the blood vessels in the liver become damaged and blocked by blood clots.
I pivotalstudiet (N = 164) blev der indberettet TLS, som kan være livstruende eller letalt, hos 4/164 (2 %) patienter.
In the pivotal study (N=164), TLS, which may be life-threatening or fatal, was reported in 4/164 (2%) patients.
2-sidet p-værdi < 0,0001
2-sided p-value < 0.0001
Der blev indberettet én grad 5 blødning/hæmoragisk hændelse (intra-abdominal blødning).
One Grade 5 bleeding/haemorrhagic event (intra-abdominal haemorrhage) was reported.
• har haft symptomer på en reaktion i forbindelse med infusion, såsom feber og kulderystelser eller åndedrætsbesvær under eller kort tid efter infusionen af BESPONSA.
• have signs and symptoms of an infusion related reaction, such as fever and chills or breathing problems during or shortly after the BESPONSA infusion.
• Et lavere antal blodlegemer, der kaldes for lymfocytter (en slags hvide blodlegemer), hvilket kan medføre en tendens til at udvikle infektion
• Reduced number of lymphocytes (a type of white blood cells) which may result in a tendency to develop infections
Patienterne kan føle sig trætte under behandling med BESPONSA (se pkt.
Patients may experience fatigue during treatment with BESPONSA (see section 4.8).
Sværhedsgrad ifølge National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, det amerikanske cancerinstituts almindelige terminologiske kriterier for bivirkninger) version 3.0.
a Severity grade according to National Cancer Institute Common Terminology Criteria for Adverse Events
Ud af de patienter, der fortsatte med HSCT efter behandling med BESPONSA, blev der indberettet VOD/SOS hos 5/11 (46 %) patienter, der fik HSCT både inden og efter behandling med BESPONSA, 13/68 (19 %) patienter, der kun fik HSCT efter behandling med BESPONSA.
Among patients who proceeded to HSCT after BESPONSA treatment, VOD/SOS was reported in 5/11 (46%) patients who received an HSCT both prior to and after BESPONSA treatment and 13/68 (19%) patients who only received an HSCT after BESPONSA treatment.
• Ændringer i hjerterytmen (kan ses på EKG)
• Changes in heart rhythm (may show on electrocardiogram)
Dosis af inotuzumab ozogamicin administreres baseret på legemsoverfladearealet (se pkt.
The dose of inotuzumab ozogamicin is administered based on body surface area (see section 4.2).
• Aktivt stof: inotuzumab ozogamicin.
• The active substance is inotuzumab ozogamicin.
Febril neutropeni (26 %) Neutropeni (49 %) Trombocytopeni (51 %) Leukopeni (35 %) Lymfopeni (18 %) Anæmi (36 %)
Febrile neutropenia (26%) Neutropenia (49%) Thrombocytopenia (51%) Leukopenia (35%) Lymphopenia (18%) Anaemia (36%)
Den maksimale tid fra rekonstituering til fuldendt administration skal være ≤ 8 timer, og der skal være ≤ 4 timer mellem rekonstituering og fortynding.
The maximum time from reconstitution through the end of administration should be ≤ 8 hours, with ≤ 4 hours between reconstitution and dilution.
Fortyndet opløsning Efter start på fortynding
Diluted solution After start of dilution
- Patienter med alvorlig, aktiv leversygdom (fx cirrose, nodulær regenerativ hyperplasi, aktiv hepatitis).
- Patients with serious ongoing hepatic disease (e.g., cirrhosis, nodular regenerative hyperplasia,
De mest almindelige bivirkninger (≥ 20 %) var trombocytopeni (51 %), neutropeni (49 %), infektion (48 %), anæmi (36 %), leukopeni (35 %), træthed (35 %), blødning (33 %), pyreksi (32 %), kvalme (31 %), hovedpine (28 %), febril neutropeni (26 %), forhøjede transaminaser (26 %), abdominalsmerter (23 %), forhøjet gamma-glutamyltransferase (21 %) og hyperbilirubinæmi (21 %).
The most common (≥ 20%) adverse reactions were thrombocytopenia (51%), neutropenia (49%), infection (48%), anaemia (36%), leukopenia (35%), fatigue (35%), haemorrhage (33%), pyrexia (32%), nausea (31%), headache (28%), febrile neutropenia (26%), increased transaminases (26%), abdominal pain (23%), increased gamma-glutamyltransferase (21%), and hyperbilirubinaemia (21%).
Overvejes BESPONSA som behandling mod recidiverende eller refraktær B-celle ALL, skal baselineværdien for CD22-positivitet være > 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 > 0% using a validated and sensitive assay is required prior to initiating treatment (see section 5.1).
Niveauet for ingen observeret bivirkning (NOAEL) for påvirkningen af reproduktionsorganer hos hunrotter og -aber var hhv. ca. 2,2 og 3,1 gange den kliniske eksponering hos mennesker baseret på AUC.
The no observed adverse effect level (NOAEL) for the effects on female reproductive organs in rats and monkeys was approximately 2.2 and 3.1 times the human clinical exposure based on AUC, respectively.
Gennemsnitsalder var 47 år (interval: 18-79 år), varigheden af første remission var < 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 < 12 months, and 55 (17%) patients had undergone an HSCT prior to receiving BESPONSA or Investigator's choice of chemotherapy.
Ved alvorlige eller livstruende infusionsrelaterede reaktioner skal behandlingen seponeres permanent (se pkt.
For severe or life-threatening infusion reactions, treatment should be permanently discontinued (see section 4.2).
Alle patienter med risiko for VOD/SOS kan muligvis ikke identificeres ved målinger udelukkende af totalbilirubin.
Monitoring only total bilirubin may not identify all patients at risk of VOD/SOS.
Hos 3 patienter med nedsat leverfunktion, defineret af NCI ODWG kategori C (total bilirubin > 1,5-3 × ULN og ASAT på alle niveauer) og 1 patient med nedsat leverfunktion, defineret af NCI ODWG kategory D (total bilirubin > 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 > 1.5-3 × ULN and AST any level) and 1 patient with hepatic impairment defined by NCI ODWG category D (total bilirubin > 3 × ULN and AST any level), inotuzumab ozogamicin clearance did not appear to be reduced.
Levertoksicitet, herunder veno-okklusiv leversygdom/sinusoidalt obstruktionssyndrom (VOD/SOS)
Hepatotoxicity, including venoocclusive liver disease/sinusoidal obstruction syndrome (VOD/SOS)
Veno-okklusiv leversygdom (sinusoidalt obstruktionssyndrom) (3 % (inden HSCT)
Venoocclusive liver disease (sinusoidal obstruction syndrome) (3% [pre-HSCT]d)
• Et lavere antal røde blodlegemer, hvilket kan medføre træthed og stakåndethed
• Reduced number of red blood cells which may result in fatigue and shortness of breath
N-acetyl-gamma-calicheamicin dimethylhydrazid in vitro blev primært metaboliseret via nonenzymatisk reduktion.
In vitro, N-acetyl-gamma-calicheamicin dimethylhydrazide was primarily metabolised via nonenzymatic reduction.
En tredje cyklus kan overvejes til patienter, der ikke opnår komplet remission (CR) eller komplet remission med delvis hæmatologisk restitution (CRi) og minimal residualsygdoms(MRD) negativitet efter 2 cyklusser (se pkt.
A third cycle may be considered for those patients who do not achieve a complete remission (CR) or complete remission with incomplete haematological recovery (CRi) and minimal residual disease (MRD) negativity after 2 cycles (see section 4.4).
Forkortelser: ALAT = alaninaminotransferase, ASAT = aspartataminotransferase, ULN = øvre normalgrænse, VOD/SOS = veno-okklusiv sygdom/sinusoidalt obstruktionssyndrom.
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal; VOD/SOS=venoocclusive disease/sinusoidal obstruction syndrome.
Dosisændringer afhængigt af varigheden af dosisafbrydelser, der skyldes toksicitet
Dose modifications depending on duration of dosing interruption due to toxicity Duration of dosing interruption due to toxicity
Det er ikke nødvendigt at justere startdosis til patienter med nedsat leverfunktion defineret som total bilirubin ≤ 1,5 × den øvre normalgrænse (ULN) og aspartataminotransferase (ASAT)/alaninaminotransferase (ALAT) ≤ 2,5 × ULN (se pkt.
No adjustment to the starting dose is required in patients with hepatic impairment defined by total bilirubin ≤ 1.5 × upper limit of normal (ULN) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN (see section 5.2).
• BESPONSA indeholder ikke bakteriostatiske konserveringsmidler.
• BESPONSA contains no bacteriostatic preservatives.
Det er ikke nødvendigt at justere startdosis til patienter med let, moderat eller svært nedsat nyrefunktion (kreatinin-clearance [CLcr] på hhv. 60-89 ml/min, 30-59 ml/min, eller 15-29 ml/min) (se pkt.
No adjustment to the starting dose is required in patients with mild, moderate, or severe renal impairment (creatinine clearance [CLcr] 60-89 mL/min, 30-59 mL/min, or 15-29 mL/min, respectively) (see section 5.2).
Gennemsnitsalder var 45 år (interval: 20-79), 76,4% havde fået ≥2 tidligere behandlinger, 31,9% havde tidligere fået HSCT og 22,2% var pH
The median age was 45 years (range 20-79); 76.4% were Salvage status ≥ 2; 31.9% had received a prior HSCT and 22.2% were Ph+.
Der er begrænset sikkerhedsinformation fra patienter med total bilirubin > 1,5 × ULN og ASAT/ALAT > 2,5 × ULN inden dosering.
There is limited safety information available in patients with total bilirubin > 1.5 × ULN and AST/ALT > 2.5 × ULN prior to dosing.
PFS er defineret som tid fra randomisering til det tidligste af følgende hændelser: død, fremskreden sygdom (inklusive objektiv progression og tilbagefald fra CR/CRi), HR var 0,568 (2-sidet p-værdi = 0,0002) og gennemsnitlig PFS var 5,6 måneder og 3,7 måneder i henholdsvis BESPONSA-arm og behandlingsarmen med investigators valg af kemoterapi.
f In the standard definition of PFS, defined as the time from date of randomisation to earliest date of the following events: death, progressive disease (including objective progression and relapse from CR/CRi), the HR was 0.568 (2-sided p-value=0.0002) and median PFS was 5.6 months and 3.7 months in the BESPONSA and Investigator's choice of chemotherapy arm, respectively.
• Unormalt højt indhold af amylase i blodet (et enzym, der er nødvendigt for fordøjelsen og omdannelse af stivelse til sukkerstoffer)
• Abnormally high levels of amylase (an enzyme needed for digestion and conversion of starch into sugars) in the blood
Abdominalsmerter (23 %) Opkastning (15 %) Diarré (17 %) Kvalme (31 %) Stomatitis (13 %) Obstipation (17 %)
Abdominal pain (23%) Vomiting (15%) Diarrhoea (17%) Nausea (31%) Stomatitis (13%) Constipation (17%)
Forkortelser: ALL = akut lymfoblastær leukæmi, EKG = elektrokardiogram, GGT = gamma-glutamyltransferase,
Abbreviations: ALL=acute lymphoblastic leukaemia; ECG=electrocardiogram; GGT=gamma-glutamyltransferase; HSCT=haematopoietic stem cell transplant.
Type I, ravfarvet hætteglas med en prop af chlorobutylgummi og flip off-hætte med krympeforsegling indeholdende 1 mg pulver.
Type I amber glass vial with chlorobutyl rubber stopper and crimp seal with flip off cap containing 1 mg of powder.
Baseret på ikke-kliniske fund kan mænds og kvinders fertilitet blive kompromitteret af behandling med inotuzumab ozogamicin (se pkt.
Based on non-clinical findings, male and female fertility may be compromised by treatment with inotuzumab ozogamicin (see section 5.3).
På grund af risikoen for bivirkninger hos ammede børn må kvinder ikke amme under behandling med BESPONSA og i mindst 2 måneder efter sidste dosis (se pkt.
Because of the potential for adverse reactions in breast-fed children, women must not breast-feed during treatment with BESPONSA and for at least 2 months after the final dose (see section 5.3).
• tidligere har haft eller er disponeret for ændring i hjertets elektriske aktivitet (forlænget QTinterval), som kan forårsage alvorlig uregelmæssig hjerterytme, tager lægemidler kendt for at forlænge QT-intervallet, og/eller har forstyrrelser i elektrolytbalancen (fx calcium, magnesium, kalium).
• have a history of, or tendency to have, QT interval prolongation (a change in electrical activity of the heart that can cause serious irregular heart rhythms), are taking medicines that are known to prolong QT interval, and/or have abnormal electrolyte (e.g., calcium, magnesium, potassium) levels.
Overdosering kan give de samme bivirkninger som dem, der ses ved den anbefalede terapeutiske dosis (se pkt.
Overdoses may result in adverse reactions that are consistent with the reactions observed at the recommended therapeutic dose (see section 4.8).
Hos patienter, der fik BESPONSA, var de mest almindelige alvorlige bivirkninger (≥ 2 %) infektion (23 %), febril neutropeni (11 %), blødning (5 %), abdominalsmerter (3 %), pyreksi (3 %), VOD/SOS (2 %) og træthed (2 %).
In patients who received BESPONSA, the most common (≥ 2%) serious adverse reactions were infection (23%), febrile neutropenia (11%), haemorrhage (5%), abdominal pain (3%), pyrexia (3%), VOD/SOS (2%), and fatigue (2%).
Ikkekliniske data tyder på, at BESPONSAs aktivitet mod cancer skyldes bindingen af ADC til tumorceller, med CD22-ekspression, efterfulgt af internalisering af ADC-CD22-komplekset og den intracellulære frigivelse af N-acetyl-gamma-calicheamicin dimethylhydrazid via hydrolytisk spaltning af bindingen.
Nonclinical data suggest that the anticancer activity of BESPONSA is due to the binding of the ADC to CD22-expressing tumour cells, followed by internalisation of the ADC-CD22 complex, and the intracellular release of N-acetyl-gamma-calicheamicin dimethylhydrazide via hydrolytic cleavage of the linker.
Hos patienter, der ikke fortsætter med HSCT, kan der administreres maksimalt 6 cyklusser.
For patients not proceeding to HSCT, a maximum of 6 cycles may be administered.
Hvis du skal i behandling med BESPONSA, skal du stoppe med at amme under behandlingen og i mindst 2 måneder efter behandlingen.
If you need treatment with BESPONSA, you must stop breast-feeding during treatment and for at least 2 months after treatment.
N-acetyl-gamma-calicheamicin dimethylhydrazid (det cytotoksiske stof, der frigives fra inotuzumab ozogamicin) var mutagent i en in vitro bakteriel mutationstest (Ames).
N-acetyl-gamma-calicheamicin dimethylhydrazide (the cytotoxic agent released from inotuzumab ozogamicin) was mutagenic in an in vitro bacterial reverse mutation (Ames) assay.
Der er ikke udført carcinogenicitetsstudier med inotuzumab ozogamicin.
Formal carcinogenicity studies have not been conducted with inotuzumab ozogamicin.
Derudover vil inotuzumab ozogamicin og N-acetyl-gamma-calicheamicin-dimethylhydrazid sandsynligvis ikke ændre eksponeringen for substrater af CYP-enzymer, og N-acetyl-gamma-calicheamicin-dimethylhydrazid vil sandsynligvis ikke ændre eksponeringen for substrater af UGT-enzymer eller transportproteiner.
In addition, inotuzumab ozogamicin and N-acetyl-gamma-calicheamicin dimethylhydrazide are unlikely to alter the exposure of substrates of CYP enzymes, and N-acetyl-gamma-calicheamicin dimethylhydrazide is unlikely to alter the exposure of substrates of UGT enzymes or major drug transporters.
+ B celle prækursor ALL skulle haft behandlingssvigt med 1 anden- eller tredjegenerations TKI og standardkemoterapi.
Patients with Ph+ B-cell precursor ALL were required to have failed treatment with at least 1 second or third generation TKI and standard chemotherapy.
Andre patientfaktorer, der også kan være forbundet med forhøjet risiko for VOD/SOS efter HSCT, inkluderer tidligere HSCT, alder ≥ 55 år, tidligere leversygdom og/eller hepatitis inden behandlingsstart, senere linjer af behandling (salvage) og et højere antal behandlingscyklusser.
include a prior HSCT, age ≥ 55 years, a history of liver disease and/or hepatitis before treatment, later salvage lines, and a greater number of treatment cycles.
Blandt de første 218 randomiserede patienter opnåede 64/88 (73 %) og 21/88 (24 %) af responderende patienter ifølge EAC CR/CRi i hhv. cyklus 1 og 2 i BESPONSA-armen.
Among the initial 218 randomised patients, 64/88 (73%) and 21/88 (24%) of responding patients per EAC achieved a CR/CRi in Cycles 1 and 2, respectively, in the BESPONSA arm. No additional patients achieved CR/CRi after Cycle 3 in the BESPONSA arm.
Tumorlysesyndrom (2 %) Hyperurikæmi (4 %)
Tumour lysis syndrome (2%) Hyperuricaemia (4%)
Forkortelser: ANC = absolut neutrofiltal, CR = komplet remission, CRi = komplet remission med delvis hæmatologisk restitution.
Abbreviations: ANC=absolute neutrophil counts; CR=complete remission; CRi=complete remission with incomplete haematological recovery.
Hvert behandlingsforløb består af 3 doser.
• Each dose is given weekly and each treatment cycle is 3 doses.
3 inden første dosis.
8 months after the last dose.
BESPONSAs sikkerhed og virkning hos patienter med recidiverende eller refraktær CD22-positiv ALL blev evalueret i et åbent, internationalt, multicenter fase 3-studie (Studie 1), hvor patienter blev randomiseret til at få BESPONSA (N = 164 (164 fik behandling)) eller investigators valg af kemoterapi (N = 162 (143 fik behandling)) specifikt fludarabin + cytarabin + granulocyt kolonistimulerendefaktor (FLAG) (N=102 (93 fik behandling)), mitoxantron/cytarabin (MXN/Ara-C) (N=38 (33 fik behandling)) eller højdosis cytarabin (HIDAC) (N=22 (17 fik behandling)).
The safety and efficacy of BESPONSA in patients with relapsed or refractory CD22-positive ALL were evaluated in an open-label, international, multicentre, Phase 3 study (Study 1) in which patients were randomised to receive BESPONSA (N=164 [164 received treatment) or Investigator's choice of chemotherapy (N=162 [143 received treatment]), specifically fludarabine plus cytarabine plus granulocyte colony-stimulating factor (FLAG) (N=102 [93 received treatment]), mitoxantrone/cytarabine (MXN/Ara-C) (N=38 [33 received treatment]), or high dose cytarabine (HIDAC) (N=22 [17 received treatment]).
MRD-negativitet blev defineret ved flowcytometri som leukæmiceller bestående af < 1 × 10 kerneholdige celler i knoglemarven.
c MRD negativity was defined by flow cytometry as leukaemic cells comprising < 1 × 10-4 (< 0.01%) of bone marrow nucleated cells.
Stigninger i QTcF interval på > 450 msek og > 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 > 450 msec and > 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).
Der var en tendens til fordel for BESPONSA, forbedringsgrad lille, for estimerede gennemsnitlige efter-baseline-scorer (hhv. BESPONSA og investigators valg) for overordnet helbredsstatus/livskvalitet (QoL) (62,1 versus 57,8), kognitiv funktion (85,3 versus 82,5), dyspnø (14,7 versus 19,4), diarré (5,9 versus 8,9), træthed (35,0 versus 39,4).
There was a trend in favour of BESPONSA, improvement grade small, for estimated mean postbaseline scores (BESPONSA and Investigator's choice, respectively) in global health status/Quality of Life (QoL) (62.1 versus 57.8), cognitive functioning (85.3 versus 82.5), dyspnoea (14.7 versus 19.4), diarrhoea (5.9 versus 8.9), fatigue (35.0 versus 39.4).
TLS forekom generelt kort efter endt infusion af inotuzumab ozogamicin og forsvandt med medicinsk behandling.
TLS occurred shortly after the end of the inotuzumab ozogamicin infusion and resolved with medical management.
• Reaktion i forbindelse med infusionen (se afsnit 2), symptomerne kan være feber og kulderystelser eller vejtrækningsbesvær under eller kort tid efter infusionen af BESPONSA.
• infusion related reaction (see section 2); signs and symptoms include fever and chills or breathing problems during or shortly after the BESPONSA infusion.
Der er rapporteret levertoksicitet, herunder svær, livstruende og nogle gange letal hepatisk VOD/SOS, hos patienter med recidiverende eller refraktær ALL, der får BESPONSA (se pkt.
Hepatotoxicity, including severe, life-threatening, and sometimes fatal hepatic VOD/SOS, was reported in patients with relapsed or refractory ALL receiving BESPONSA (see section 4.8).
Hos patienter, der udvikler abnorme levertal, anbefales hyppigere monitorering af levertallene og kontrol for symptomer på levertoksicitet.
For patients who develop abnormal liver tests, liver tests and clinical signs and symptoms of hepatotoxicity should be monitored more frequently.
Fortæl lægen, hvis du bliver svimmel, ør eller besvimer.
Tell your doctor if you have symptoms, such as dizziness, lightheadedness or fainting.
4.4 vedrørende klinisk behandling af myelosuppression/cytopeni.
For clinical management of myelosuppression/cytopenias, see section 4.4.
I toksicitetsstudier med gentagne doser hos rotter og aber omfattede de fund, der vedrørte reproduktionsevnen hos hunner, atrofi af ovarier, uterus, vagina og mælkekirtler.
In repeat dose toxicity studies in rats and monkeys, female reproductive findings included atrophy of ovaries, uterus, vagina, and mammary gland.
Anvisninger i rekonstituering og fortynding af BESPONSA inden administration er anført i pkt.
For instructions on reconstitution and dilution of BESPONSA before administration, see section 6.6.
Bivirkninger indberettet fra patienter med recidiverende eller refraktær B-celle prækursor ALL, som fik BESPONSA
Adverse reactions reported in patients with relapsed or refractory B-cell precursor ALL who received BESPONSA
En tredje cyklus kan overvejes til patienter, der ikke opnår CR/CRi og MRDnegativitet efter 2 cyklusser.
A third cycle may be considered for those patients who do not achieve a CR/CRi and MRD negativity after 2 cycles.
I tilføjelse hertil, var sandsynligheden for overlevelse ved 24 måneder i BESPONSA-armen 38,0 % (95% CI: 27,4-48,5) for patienter som fik opfølgende HSCT sammenlignet med 8,0 % (95 % CI: 3,3-15,3) for patienter, som ikke fik en opfølgende HSCT.
Furthermore, at month 24, the survival probability was 38.0% (95% CI: 27.4, 48.5) for patients who underwent a follow-up HSCT compared to 8.0% (95% CI: 3.3, 15.3) for patients who did not undergo a follow-up HSCT in the BESPONSA arm.
Inotuzumab ozogamicin er ikke undersøgt hos patienter med nyresygdom i slutstadiet (se pkt.
Inotuzumab ozogamicin has not been studied in patients with end-stage renal disease (see section 4.2).
Patienter med recidiverende eller refraktær ALL, der havde fået 1 eller 2 tidligere behandlingsregimer for ALL - Studie 1
Patients with relapsed or refractory ALL who have received 1 or 2 prior treatment regimens for ALL - Study 1
Veno-okklusiv sygdom kan være dødelig og er forbundet med hurtig vægtstigning, smerter i den øverste højre side af maven, forstørret lever, væskeophobning som giver udspiling af maven, og blodprøver som viser forhøjet bilirubin og/eller leverenzymer (kan give gulfarvning af hud og øjne).
Venoocclusive disease may be fatal and is associated with rapid weight gain, pain in the upper right side of your abdomen (belly), increase in the size of the liver, build-up of fluid causing abdominal swelling, and blood tests showing increases in bilirubin and/or liver enzymes (that may result in yellowing of the skin or eyes).
I fase 2 delen af studiet skulle patienterne have fået mindst 2 tidligere behandlingsregimer for ALL og patienter med Ph
In the Phase 2 portion of the study, patients had to have received at least 2 prior treatment regimens for ALL and patients with Ph+ B-cell ALL had to have failed treatment with at least 1 TKI.
Seponer behandlingen permanent (se pkt.
Permanently discontinue treatment (see section 4.4).