natgillin/translations-raw huggingface dataset:
Yondelis er indiceret til behandling af patienter med fremskredet bløddelssarkom (STS) efter fejlslagen behandling med antracykliner og ifosfamid, eller til patienter som er uegnede til at modtage disse stoffer.
Yondelis is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents.
Yondelis skal administreres under overvågning af en læge, der har erfaring i brugen af kemoterapi.
Yondelis must be administered under the supervision of a physician experienced in the use of chemotherapy.
Yondelis bør kun indgives af kvalificerede onkologer eller andet sundhedspersonale, der er specialiseret i indgivelse af cytotoksiske lægemidler.
Its use should be confined to qualified oncologists or other health professionals specialised in the administration of cytotoxic agents.
Den anbefalede dosis er 1, 5 mg/ m2 legemsoverflade, indgivet som en intravenøs infusion over 24 timer med et interval på tre uger mellem cyklusserne.
The recommended dose is 1.5 mg/ m2 body surface area, administered as an intravenous infusion over 24 hours with a three-week interval between cycles.
6. 6).
Administration through a central venous line is strongly recommended (see section 6.6).
Alle patienter skal have indgivet 20 mg dexametason intravenøst 30 minutter inden indgivelse af Yondelis; ikke blot som anti- emetisk profylakse, men også fordi det tilsyneladende har leverbeskyttende virkning.
All patients must receive 20 mg of dexamethasone intravenously 30 minutes prior to Yondelis; not only as anti-emetic prophylaxis, but also because it appears to provide hepatoprotective effects.
Yderligere anti- emetika kan administreres efter behov.
Additional anti-emetics may be administered as needed.
- Absolut neutrofiltal (ANC) ≥ 1. 500/ mm3
- Absolute neutrophil count (ANC) ≥ 1,500/ mm3
- Blodpladetal ≥ 100. 000/ mm3
- Platelet count ≥ 100,000/ mm3
- Bilirubin ≤ øvre grænse for normal (upper limit of normal - ULN)
- Bilirubin ≤ upper limit of normal (ULN)
- Alkalisk fosfatase ≤ 2, 5 ULN (overvej hepatiske isoenzymer 5- nukleotidase eller GGT, hvis
- Alkaline phosphatase ≤ 2.5 ULN (consider hepatic isoenzymes 5-nucleotidase or GGT, if the
forhøjelsen kunne have ossøse årsager).
elevation could be osseous in origin).
- Alanin- aminotransferase (ALT) og aspartat- aminotransferase (AST) ≤ 2, 5 x ULN
- Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 x ULN
- Kreatininclearance ≥ 30 ml/ min
- Creatinine clearance ≥ 30 ml/ min
- Kreatinfosfokinase (CPK) ≤ 2, 5 ULN
- Creatine phosphokinase (CPK) ≤ 2.5 ULN
- Hæmoglobin ≥ 9 g/ dl
- Haemoglobin ≥ 9 g/ dl
Der bør gives den samme dosis i alle cyklusser, forudsat at der ikke observeres grad 3- 4- toksicitet, og forudsat at patienten opfylder kriterierne for genbehandling.
The same dose should be given for all cycles provided that no grade 3-4 toxicities are seen and that the patient fulfils the re-treatment criteria.
Hvis en eller flere af de nedenstående hændelser optræder på et hvilket som helst tidspunkt mellem cyklusserne, skal dosis reduceres til 1, 2 mg/ m2 i de efterfølgende cyklusser:
If any of the following events occur at any time between cycles, the dose must be reduced to 1.2 mg/ m2 for subsequent cycles:
- Neutropeni < 500/ mm3 varende i mere end 5 dage eller associeret med feber eller infektion
- Neutropenia < 500/ mm3 lasting for more than 5 days or associated with fever or infection
- Trombocytopeni < 25. 000/ mm3
- Thrombocytopenia < 25,000/ mm3
- Forhøjelse af bilirubin > ULN og/ eller alkalisk fosfatase > 2, 5 x ULN
- Increase of bilirubin > ULN and/ or alkaline phosphatase > 2.5 x ULN
21
- Increase of aminotransferases (AST or ALT) > 2.5 x ULN which has not recovered by day 21
- En hvilken som helst anden grad 3 - eller 4- bivirkning (såsom kvalme, opkastning, træthed)
- Any other grade 3 or 4 adverse reactions (such as nausea, vomiting, fatigue)
Hvis en af disse typer toksicitet optræder igen i efterfølgende cyklusser hos en patient, der udviser klinisk gavn af behandlingen, skal dosis reduceres yderligere til 1 mg/ m2.
If any of these toxicities reappear in subsequent cycles in a patient exhibiting clinical benefit, the dose may be further reduced to 1 mg/ m2.
I kliniske forsøg var der ingen prædefinerede grænser for antallet af behandlingscyklusser.
In clinical trials, there were no pre-defined limits to the number of cycles administered.
Trabectedin er blevet administreret i seks eller flere cyklusser hos 168 ud af de 569 (29, 5%) patienter, der blev behandlet med den foreslåede dosis efter den foreslåede plan.
Trabectedin has been administered for 6 or more cycles in 168 out of 569 (29.5%) patients treated with the proposed dose and schedule.
Dette regime er blevet anvendt i op til 38 cyklusser.
This regime has been used for up to 38 cycles.
Sikkerheden og effekten af trabectedin hos pædiatriske patienter er endnu ikke blevet fastslået.
The safety and efficacy of trabectedin in paediatric patients have not yet been established.
Derfor bør dette lægemiddel ikke anvendes til børn og unge, før yderligere data bliver tilgængelige.
Therefore, this medicinal product must not be used in children and adolescents until further data become available.
Der er ikke udført specifikke studier hos ældre patienter.
No specific studies in elderly patients have been performed.
Alt i alt var 20% af de 1164 patienter i den integrerede sikkerhedsanalyse over 65 år.
Overall 20% of the 1164 patients in the integrated safety analysis were over 65 years.
Der blev ikke observeret relevante forskelle i sikkerhedsprofilen i denne patientpopulation.
No relevant differences in the safety profile were seen in this patient population.
3 Patienter med nedsat leverfunktion
Patients with impaired hepatic function
Der er ikke foretaget undersøgelser med det foreslåede regime hos patienter med nedsat leverfunktion.
3 No studies with the proposed regime have been conducted in patients with liver dysfunction.
4. 4).
Patients with elevated bilirubin must not be treated with Yondelis (see section 4.4).
4. 4).
Studies including patients with severe renal insufficiency (creatinine clearance < 30 ml/ min) have not been conducted and therefore Yondelis must not be used in this patient population (see section 4.4).
5. 2) er dosisjusteringer ikke påkrævet hos patienter med mild eller moderat nyreinsufficiens.
Considering the pharmacokinetic characteristics of trabectedin (see section 5.2), no dose adjustments are warranted in patients with mild or moderate renal impairment.
6. 6.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
- Overfølsomhed over for trabectedin eller over for et eller flere af hjælpestofferne
- Hypersensitivity to trabectedin or to any of the excipients
- Samtidig alvorlig eller ukontrolleret infektion
- Concurrent serious or uncontrolled infection
4. 6)
- Breast-feeding (see section 4.6)
4. 4)
- Combination with yellow fever vaccine (see section 4.4)
4. 4).
Patients with elevated bilirubin must not be treated with trabectedin (see section 4.2).
4. 2).
Trabectedin must not be used in patients with creatinine clearance < 30 ml/ min (see section 4.2).
Grad 3 - eller 4- neutropeni og trombocytopeni associeret med trabectedin- behandling er indberettet meget hyppigt.
Grades 3 or 4 neutropenia and thrombocytopenia associated with trabectedin therapy have been very commonly reported.
4. 2).
A full blood cell count including differential and platelet count must be performed at baseline, weekly for the first two cycles and then once between cycles (see section 4.2).
4. 2).
Anti-emetic prophylaxis with dexamethasone must be administered to all patients (see section 4.2).
Rhabdomyolyse og alvorlige CPK- forhøjelser (> 10 x ULN)
Rhabdomyolysis and severe CPK elevations (> 10 x ULN)
4. 2).
Trabectedin must not be used in patients with CPK > 2.5 ULN (see section 4.2).
4 abnormiteter i leverfunktionstests og/ eller nyresvigt.
Rhabdomyolysis has been uncommonly reported, usually in association with myelotoxicity, severe liver function test abnormalities and/ or renal failure.
CPK bør derfor monitoreres nøje, hvis der er mistanke om, at en patient lider af en af disse typer toksicitet.
Therefore, CPK should be closely monitored whenever a patient may be experiencing any of these toxicities.
Hvis der forekommer rhabdomyolyse, skal der omgående iværksættes støttende foranstaltninger såsom parenteral hydrering, alkalinisering af urinen og dialyse, som indiceret.
4 parenteral hydration, urine alkalinisation and dialysis should be promptly established, as indicated.
Der bør udvises forsigtighed, hvis lægemidler, der associeres med rhabdomyolyse (f. eks. statiner), administreres samtidig med trabectedin, da risikoen for rhabdomyolyse kan være forøget.
Caution should be taken if medicinal products associated with rhabdomyolysis (e. g. statins), are administered concomitantly with trabectedin, since the risk of rhabdomyolysis may be increased
Der er hos de fleste patienter indberettet reversible, akutte forhøjelser af aspartat- aminotransferase (AST) og alanin- aminotransferase (ALT).
Reversible acute increases in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) have been reported in most patients.
4. 5).
Co-administration of Yondelis with potent inhibitors of the enzyme CYP3A4 should be avoided (see section 4.5).
Hvis dette ikke er muligt, kræves der nøje monitorering af toksicitet, og det bør overvejes at nedsætte trabectedin- dosis.
If this is not possible, close monitoring of toxicities are required and dose reductions of trabectedin should be considered.
4. 3 og 4. 5).
Combination of trabectedin with phenytoin or live attenuated vaccines is not recommended and with yellow fever vaccine is specifically contraindicated (see sections 4.3 and 4.5).
4. 5).
The concomitant use of trabectedin with alcohol must be avoided (see section 4.5).
4. 6).
Men in fertile age and women of childbearing potential must use effective contraception during treatment and 3 months thereafter for women and immediately inform the treating physician if a pregnancy occurs, and 5 months after treatment for men (see section 4.6).
Denne medicin indeholder kalium, mindre end 1 mmol (39 mg) pr. hætteglas, dvs. den er i det væsentligste ” kaliumfri ”.
This medicine contains potassium, less than 1 mmol (39 mg) per vial, i. e. essentially “ potassium-free”.
Der er ikke udført in vivo- interaktionsundersøgelser.
In vivo interaction studies have not been performed.
Da trabectedin hovedsagelig metaboliseres ved CYP 3A4, kunne samtidig administration af stoffer, der hæmmer dette isoenzym, f. eks. ketoconazol, fluconazol, ritonavir eller clarithromycin nedsætte metaboliseringen og øge trabectedin - koncentrationerne.
Since trabectedin is metabolised mainly by CYP3A4, co-administration of substances that inhibit this isoenzyme e. g. ketoconazole, fluconazole ritonavir or clarithromycin could decrease metabolism and increase trabectedin concentrations.
Hvis der er behov for sådanne kombinationer, kræves der nøje monitorering af toksicitet (se pkt.
If such combinations are needed, close monitoring of toxicities is required (see section 4.4).
På samme måde kan samtidig administration af potente inducere af dette enzym (f. eks. rifampicin, phenobarbital, prikbladet perikon) nedsætte den systemiske eksponering for trabectedin.
Likewise co-administration with potent inducers of this enzyme (e. g. rifampicin, phenorbarbital, Saint John’ s Wort) may decrease the systemic exposure to trabectedin.
4. 4).
Alcohol consumption must be avoided during treatment with trabectedin due to the hepatotoxicity of the medicinal product (see section 4.4).
Prækliniske data har påvist, at trabectedin er et P- gp- substrat.
Preclinical data have demonstrated that trabectedin is a substrate to P-gp.
Samtidig administration af hæmmere af P- gp, f. eks. cyclosporin og verapamil, kan ændre trabectedins distribution og/ eller elimination.
Concomitant administration of inhibitors of Pgp, e. g. cyclosporine and verapamil, may alter trabectedin distribution and/ or 5 elimination.
Relevansen af denne interaktion, f. eks.
The relevance of this interaction e. g.
CNS- toksicitet, er ikke blevet fastslået.
CNS toxicity has not been established.
Der foreligger ikke tilstrækkelige kliniske data om eksponering for trabectedin under graviditet.
No sufficient clinical data on exposed pregnancies are available.
Trabectedin bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
Trabectedin should not be used during pregnancy unless clearly necessary.
5. 3), og patienten skal monitoreres omhyggeligt.
If it is used during pregnancy, the patient must be informed of the potential risk to the foetus (see section 5.3) and be monitored carefully.
5. 3).
Men in fertile age and women of childbearing potential must use effective contraception during treatment and 3 months thereafter for women and immediately inform the treating physician if a pregnancy occurs (see section 5.3) and 5 months after treatment for men (see section 4.4).
Der bør inden behandlingen søges rådgivning vedrørende indsamling og opbevaring af sæd på grund af risikoen for uoprettelig ufrugtbarhed på grund af behandlingen med Yondelis.
Advice on conservation of sperm should be sought prior to treatment because of the possibility of irreversible infertility due to therapy with Yondelis.
Hvis der opstår graviditet under behandlingen, skal det overvejes at yde genetisk rådgivning.
If pregnancy occurs during treatment the possibility of genetic counselling should be considered.
4. 3).
Breast-feeding is contraindicated during treatment and 3 months thereafter (see section 4.3).
Imidlertid er der indberettet træthed og/ eller asteni hos patienter, der fik trabectedin.
However, fatigue and/ or asthenia have been reported in patients receiving trabectedin.
Patienter, der oplever træthed og/ eller asteni under behandlingen, må ikke føre motorkøretøj eller betjene maskiner.
Patients who experience any of these events during therapy must not drive or operate machines.
Disse patienter blev behandlet op til april 2007 med det anbefalede behandlingsregime i forbindelse med flere kræfttyper, herunder bløddelssarkom, brystkræft, osteosarkom, æggestokskræft, gastrointestinal stromal tumor (GIST), melanom og nyrekarcinom.
Unless otherwise specified, the following safety profile of Yondelis is based on the evaluation in clinical trials of 569 patients treated up to April 2007 with the recommended treatment regime in several cancer types including soft tissue sarcoma, breast cancer, osteosarcoma, ovarian cancer, GIST, melanoma and renal carcinoma.
Cirka 91% af patienterne kan forventes at få bivirkninger af en hvilken som helst grad.
Approximately 91% of patients can be expected to have adverse reactions of any grade.
Omkring 40% af patienterne forventes at få bivirkninger af sværhedsgrad 3 eller 4.
Around 40% of patients are expected to have adverse reactions of grade 3 or 4 severity.
De mest almindelige bivirkninger af en hvilken som helst sværhedsgrad var: kvalme, træthed, opkastning, anoreksi, neutropeni og forhøjelser af AST/ ALT.
The most common adverse reactions of any severity grade were nausea, fatigue, vomiting, anorexia, neutropenia, and increases in AST/ ALT.
6 Fatale bivirkninger er forekommet hos 1, 9% af patienterne.
Fatal adverse reactions have occurred in 1.9% of patients.
De var ofte resultatet af en kombination af flere hændelser herunder pancytopeni, febril neutropeni, hvoraf nogle var med sepsis, leverlidelser, nyresvigt og rhabdomyolyse.
They were often the result of a combination of events including pancytopenia, febrile neutropenia, some of them with sepsis, hepatic involvement, renal failure and rhabdomyolysis.
Hyppigheden af de nedenfor opstillede bivirkninger er klassificeret som meget almindelig (≥ 1/ 10), almindelig (≥ 1/ 100 til < 1/ 10) og ikke almindelig (≥ 1/ 1000 til < 1/ 100).
The frequencies of the adverse reactions reported below are classified as very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10) and uncommon (≥ 1/ 1000 to < 1/ 100).
Tabellen nedenfor viser de bivirkninger, der blev indberettet hos ≥ 1% af patienterne ifølge systemorganklasserne i henhold til MedDRA- databasen.
6 The table below displays the adverse reactions reported in ≥ 1% of patients according to the standard MedDRA system organ class.
Der er både anvendt bivirkninger og laboratorieværdier til at udregne hyppighederne.
Both adverse events and laboratory values have been used to provide frequencies.
7 Systemorganklasse
7 System Organ Class Investigations
Bivirkninger indberettet hos ≥ 1% af patienterne i kliniske forsøg ved det anbefalede regime [1, 5 mg/ m2, 24- timers infusion hver 3. uge (24- h q3wk)]
Adverse reactions reported in ≥ 1% of patients in clinical trials at the recommended regime [1.5 mg/ m2, 24 hour infusion every 3 weeks (24-h q3wk)] Very Common Blood creatine phosphokinase increased, Blood creatinine increased, Blood albumin decreased Common Weight decreased
Undersøgelser
Blood and Lymphatic System Disorders
Meget almindelige Blodkreatinfosfokinase øget, blodkreatinin øget, blodalbumin sænket Almindelig Vægttab
Very Common Neutropenia, Thrombocytopenia, Anaemia, Leukopenia Common Febrile neutropenia
Blod og lymfesystem
Nervous System Disorders
Meget almindelige Neutropeni, trombocytopeni, anæmi, leukopeni Almindelig Febril neutropeni
Very Common Headache Common Peripheral sensory neuropathy, Dysgeusia, Dizziness, Paraesthesia
Nervesystemet
Respiratory, Thoracic and Mediastinal Disorders
Meget almindelig Hovedpine Almindelige Perifer sensorisk neuropati, dysgeusi, svimmelhed, paræstesi
Common Dyspnoea, Cough
Luftveje, thorax og mediastinum Mave- tarmkanalen
Gastrointestinal disorders
Almindelige Dyspnø, hoste Meget almindelige Opkastning, kvalme, forstoppelse Almindelige Diare, stomatitis, underlivssmerte, dyspepsi, mavesmerter
Very Common Vomiting, Nausea, Constipation Common Diarrhoea, Stomatitis, Abdominal pain, Dyspepsia, Upper abdominal pain
Hud og subkutane væv Knogler, led, muskler og bindevæv
Skin and Subcutaneous Tissue Disorders
Almindelig Alopeci Almindelige myalgi, artralgi, rygsmerte
Common Alopecia
Metabolisme og ernæring
Musculoskeletal and Connective Tissue Disorders
Meget almindelig Anoreksi Almindelige Dehydrering, nedsat appetit, hypokaliæmi
Common Myalgia, Arthralgia, Back pain
Infektioner og parasitære sygdomme
Metabolism and
Almindelig Infektion
Very Common
Vaskulære sygdomme Almene symptomer og reaktioner på administrationsstedet
Nutrition DisordersAnorexia Common Dehydration, Decreased appetite, Hypokalaemia Infections and Infestations Vascular Disorders
Almindelige Hypotension, hedeture/ blussen Meget almindelige Træthed, asteni Almindelige Pyreksi, ødemer, perifert ødem, reaktion ved injektionsstedet
Common Infection Common Hypotension, Flushing
Meget almindelige Hyperbilirubinæmi, alanin- aminotransferase forhøjet, aspartat- aminotransferase forhøjet, alkalisk fosfatase i blodet øget, gamma- glutamyltransferase forhøjet
Very Common Hyperbilirubinemia, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Gamma-glutamyltransferase increased
8 De hyppigste bivirkninger
8 Most frequent adverse reactions
Blod og lymfesystem
Blood and Lymphatic system disorders
Neutropeni optrådte hos 77% af patienterne.
Neutropenia occurred in 77% of patients.
Grad 3 - og 4- neutropeni optrådte hos henholdsvis 26% og 24% af patienterne.
Grade 3 and 4 neutropenia occurred in 26% and 24% of patients respectively).
Febril neutropeni optrådte hos 2% af patienterne og i < 1% af cyklusserne.
The analysis per cycle showed that neutropenia of grade 3 and 4 occurred in approximately 19% and 8% of cycles respectively Febrile neutropenia occurred in 2% of patients and in < 1% of cycles.
Neutropeni fulgte et forudsigeligt mønster med hurtig start og reversibilitet og associeredes sjældent med feber eller infektion.
Neutropenia followed a predictable pattern of rapid onset and reversibility, and was rarely associated with fever or infection.
Grad 3 - og 4- trombocytopeni forekom hos henholdsvis 11% og 2% af patienterne.
Grade 3 and 4 thrombocytopenia occurred in 11% and 2% of patients respectively.
Analysen per cyklus viste, at trombocytopeni grad 3 og 4 forekom i cirka henholdsvis 3% og < 1% af cyklusserne.
The analysis per cycle showed that thrombocytopenia of grade 3 and 4 occurred in approximately 3% and < 1% of cycles respectively.
Blødningshændelser associeret med trombocytopeni optrådte hos < 1% af patienterne.
Bleeding events associated to thrombocytopenia occurred in < 1% of patients.
Anæmi optrådte hos 93% af patienterne, men 46% af patienterne var anæmiske ved baseline.
Anaemia occurred in 93% of patients although 46% of patients were anaemic at baseline.
Grad 3 - og 4- anæmi optrådte hos henholdsvis 10% og 3% af patienterne.
Grade 3 and 4 anaemia occurred in 10% and 3% of patients respectively.
Analysen per cyklus viste, at anæmi grad 3 og 4 forekom i cirka henholdsvis 3% og 1% af cyklusserne.
The analysis per cycle showed that anaemia of grade 3 and 4 occurred in approximately 3% and 1% of cycles respectively.
AST/ ALT- forhøjelser:
AST/ ALT increases:
Forbigående grad 3- forhøjelser af aspartat- aminotransferase (AST) og alanin - aminotransferase (ALT) blev observeret hos henholdsvis 38% og 44% af patienterne og grad 4 - forhøjelser hos henholdsvis 3% og 7% af patienterne.
Transient grade 3 increases of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were observed in 38% and 44% of the patients and grade 4 elevations in 3% and 7% of the patients, respectively.
Middeltid til at nå peak- værdier var 5 dage for både AST og ALT.
The median time to reach the peak values was 5 days for both AST and ALT.
4. 4).
Most of the values had decreased to grade 1 or resolved by day 14-15 (see section 4.4).
Grad 3- forhøjelser af AST og ALT forekom i henholdsvis 12% og 20% af cyklusserne.
Grade 3 elevations of AST and ALT occurred in 12% and 20% of cycles respectively.
Grad 4- forhøjelser af AST og ALT forekom i henholdsvis 1% og 2% af cyklusserne.
Grade 4 elevations of AST and ALT occurred in 1% and 2% of cycles respectively.
De fleste transaminaseforhøjelser blev inden for 15 dage forbedret til grad 1 eller til de niveauer, der blev målt inden behandlingen, og i mindre end 2% af cyklusserne gik der mere end 25 dage, inden værdierne blev normaliseret.
Most transaminase elevations improved to grade 1 or to pre-retreatment levels within 15 days, and less than 2% of cycles had recovering times longer than 25 days.
ALT - og AST- forhøjelser fulgte ikke et kumulativt mønster, men viste en tendens i retning af mindre forhøjelser over tid.
ALT and AST increases did not follow a cumulative pattern but showed a tendency towards less severe elevations over time.
Der blev observeret grad 1 - til 2- bilirubin- forhøjelser hos 23% af patienterne.
Grades 1 to 2 bilirubin increases were observed in 23% of the patients.
Grad 3- hyperbilirubinæmi optrådte hos 1% af patienterne.
Grade 3 hyperbilirubinemia occurred in 1% of patients.
Kliniske tilfælde af svær leverskade var ualmindelige med mindre end 1% forekomst af individuelle tegn og symptomer herunder gulsot, hepatomegali eller leversmerte.
Clinical manifestations of severe hepatic injury were uncommon with a lower than 1% incidence of individual signs and symptoms including jaundice, hepatomegaly or liver pain.
Mortalitet, hvor der blev konstateret beskadigelse af leveren, forekom hos mindre end 1% af patienterne.
Mortality in the presence of hepatic injury occurred in less than 1% of patients.
Kvalme, opkastning, diare og forstoppelse:
Nausea, vomiting, diarrhoea and constipation:
Kvalme og opkastning blev rapporteret hos henholdsvis 63% og 38, 5% af patienterne.
Nausea and vomiting were reported in 63 and 38.5% of patients respectively.
Grad 3- 4- kvalme og - opkastning blev rapporteret hos henholdsvis 6% og 6, 5% af patienterne.
Grade 3-4 nausea and vomiting were reported in 6% and 6.5% of patients, respectively.
Grad 3- 4- diare og - forstoppelse blev rapporteret hos mindre end 1% af patienterne.
Grade 3-4 diarrhoea and constipation were reported in less than 1% of patients.
Stomatitis:
Stomatitis: