FrancophonIA/ELRC3.0 huggingface dataset:
English: Post-marketing experience
Danish: Erfaring efter markedsføring:
English: The median times to progression in these endpoints ranged from 0.7 to 2.1 months longer for TMZ than for procarbazine (log rank p=< 0.01 to 0.03).
Danish: Median-tiden til progression af disse endpoints varierede fra at være 0,7 til 2,1 måneder længere for TMZ end for procarbazin (log rank p = < 0,01 til 0,03).
English: When laboratory abnormalities and adverse events were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic events were observed in 8 % of the patients.
Danish: Når unormale laboratorieværdier og bivirkninger blev slået sammen på tværs af konkomitante og monoterapi-behandlingsfaser, blev Grad 3- eller Grad 4-neutrofilabnormaliteter inklusive neutropeni-bivirkninger set hos 8 % af patienterne.
English: - if you have liver or kidney problems, your dose of Temozolomide SUN may need to be adjusted.
Danish: - hvis du har lever- eller nyreproblemer, skal din dosis af Temozolomide SUN muligvis justeres.
English: During the concomitant phase, your doctor will start Temozolomide SUN at a dose of 75 mg/m2 (usual dose).
Danish: Under den konkomiterende fase starter lægen Temozolomide SUN ved en dosis på 75 mg/m2 (normal dosis).
English: Cases of fatal respiratory failure have been reported in patients using TMZ, in particular in combination with dexamethasone or other steroids.
Danish: Tilfælde af dødeligt åndedrætssvigt er set hos patienter, som fik TMZ, især i kombination med dexamethason eller andre steroieder.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER BLISTER
English: Rare (may affect up to 1 in 1,000 people): cough, infections including pneumonia.
Danish: Sjælden (kan påvirke op til 1 ud af 1.000): hoste, infektioner, inklusive lungebetændelse.
English: In the randomised active-controlled trial, the PFS at 6 months was significantly greater for TMZ than for procarbazine (21 % vs 8 %, respectively - chi-square p=0.008) with median PFS of 2.89 and 1.88 months respectively (log rank p=0.0063).
Danish: I den randomiserede aktive kontrollerede undersøgelse var 6 måneders PFS signifikant større for TMZ end for procarbazin (henholdsvis 21 % versus 8 % - chi-square p=0,008) med median PFS på henholdsvis 2,89 og 1,88 måneder (log rank p = 0,33).
English: You will again take Temozolomide SUN once daily for 5 days followed by 23 days without Temozolomide SUN.
Danish: Du skal igen tage Temozolomide SUN én gang dagligt i 5 dage efterfulgt af 23 dage uden Temozolomide SUN.
English: TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen1-yl)imidazole-4-carboxamide (MTIC).
Danish: TMZ hydrolyseres spontant ved fysiologisk pH primært til det aktive stof, 3-methyl-(triazen-1yl)imidazol-4-carboxamid (MTIC).
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Brug altid dette lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: At 6 months, the fraction of surviving patients was significantly higher in the TMZ arm (60 %) compared with the procarbazine arm (44 %) (chi-square p=0.019).
Danish: Efter 6 måneder var andelen af overlevende patienter signifikant større i TMZ-gruppen (60 %) sammenlignet med procarbazingruppen (44 %) (chi-square p = 0,019).
English: You will take Temozolomide SUN only once daily for the first 5 days.
Danish: Du skal kun tage Temozolomide SUN én gang dagligt i de første 5 dage.
English: You will take your new dose of Temozolomide SUN once daily for the first 5 days (“dosing days”) of each cycle.
Danish: Du skal tage den nye dosis af Temozolomide SUN én gang dagligt i de første 5 dage ("doseringsdage") i hver cyklus.
English: In post-marketing cases, meningoencephalitis herpetic (including fatal cases) has been observed in patients receiving TMZ in combination with radiotherapy, including cases of concomitant steroids administration.
Danish: Efter markedsføring er der observeret tilfælde af meningoencephalitis herpetica (herunder dødsfald) hos patienter, der fik TMZ i kombination med radioterapi, herunder tilfælde af samtidig administration af steroider.
English: Temozolomide SUN contains lactose
Danish: Temozolomide SUN indeholder lactose
English: Signs of allergic reaction include itchiness, breathlessness or wheezing, or swelling of the face, lips, tongue or throat.
Danish: Tegn på en allergisk reaktion omfatter kløe, kortåndethed eller hvæsende vejrtrækning eller hævelse i ansigt, læber, tunge eller hals.
English: Temozolomide SUN contains a medicine called temozolomide.
Danish: Temozolomide SUN indeholder en medicin, som kaldes temozolomid.
English: If ANC falls to < 1.0 x 109/l or the platelet count is < 50 x 109/l during any cycle, the next cycle should be reduced one dose level (see section 4.2).
Danish: Hvis ANC falder til < 1,0 x 109/l, eller trombocyttallet er < 50 x 109/l i en behandlingsserie, skal næste behandlingsserie reduceres med et dosisniveau (se pkt.
English: You should stop breast-feeding while receiving treatment with Temozolomide SUN.
Danish: Du bør stoppe amning, mens du bliver behandlet med Temozolomide SUN.
English: Patients should be advised to keep capsules out of the sight and reach of children, preferably in a locked cupboard.
Danish: Patienter skal anbefales, at kapsler skal holdes utilgængeligt for børn, fortrinsvist i et låst skab.
English: This was followed by monotherapy TMZ (150-200 mg/m2) on Days 1-5 of every 28-day cycle for up to 6 cycles, starting 4 weeks after the end of RT.
Danish: Dette blev efterfulgt af monoterapi med TMZ (150-200 mg/m2) på dag 1 - 5 i hver 28-dags-serie i op til 6 serier, startende 4 uger efter afsluttet strålebehandling.
English: Temozolomide SUN is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme.
Danish: Temozolomide SUN bruges til behandling af bestemte typer hjernetumorer: - hos voksne med nyligt diagnosticerede glioblastoma multiforme.
English: Temozolomide SUN may cause permanent infertility.
Danish: Temozolomide SUN giver muligvis permanent ufrugtbarhed.
English: Opportunistic infections and reactivation of infections Opportunistic infections (such as Pneumocystis jirovecii pneumonia) and reactivation of infections (such as HBV, CMV) have been observed during the treatment with TMZ (see section 4.8).
Danish: Opportunistiske infektioner og reaktivering af infektioner Der er set opportunistiske infektioner (såsom Pneumocystis jirovecii lungebetændelse) og reaktivering af infektioner (såsom HBV, CMV) under behandling med TMZ (se pkt.
English: At the start of Cycle 2, the dose is escalated to 200 mg/m2 if the CTC non-haematological toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/l, and the thrombocyte count is ≥ 100 x 109/l.
Danish: Ved begyndelsen af serie 2 øges dosis til 200 mg/m2, hvis CTC ikke-hæmatologisk toksicitet for serie 1 er Grad ≤ 2 (undtagen for alopeci, kvalme og opkastning), absolut antal neutrofile (ANC) er ≥ 1.5 x 109/log trombocyttal er ≥ 100 x 109/l.
English: Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temozolomide SUN only
Danish: Patienter med tilbagevendende eller forværrede tumorer (malignt gliom, f.eks. glioblastoma multiforme eller anaplastisk astrocytom), der kun tager Temozolomide SUN
English: Prior to dosing, the following laboratory parameters must be met: ANC ≥ 1.5 x 109/l and platelet count ≥ 100 x 109/l.
Danish: Forud for dosering skal følgende laboratorieparametre være opfyldte: ANC ≥ 1.5 x 109/l og trombocyttal ≥ 100 x 109/l.
English: What you need to know before you take Temozolomide SUN Do not take Temozolomide SUN
Danish: Det skal du vide, før du begynder at tage Temozolomide SUN Tag ikke Temozolomide SUN
English: New or reactivated (recurring) cytomegalovirus infections and reactivated hepatitis B virus infections have been uncommonly reported.
Danish: Der er rapporteret nye eller tilbagevendende cytomegalovirusinfektioner og tilbagevendende hepatitis B-virus infektioner med hyppigheden ”ikke almindelig”.
English: Dermatitis, dry skin, erythema, pruritus
Danish: Dermatitis, tør hud, erythem, kløe
English: Reproductive system and breast disorders Uncommon:
Danish: Det reproduktive system og mammae Ikke almindelige:
English: Contents of the pack and other information What Temozolomide SUN contains
Danish: Pakningsstørrelser og yderligere oplysninger Temozolomide SUN indeholder
English: Very common (may affect more than 1 in 10 people): loss of appetite, headache, constipation
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10): manglende appetit, hovedpine, forstoppelse
English: Erythema, pigmentation abnormal, sweating increased
Danish: Erythem, unormal pigmentering, øget svedtendens
English: Endocrine disorders Uncommon:
Danish: Det endokrine system Ikke almindelig:
English: If you forget to take Temozolomide SUN
Danish: Hvis du har glemt at tage Temozolomide SUN
English: Temozolomide SUN in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Danish: Temozolomide SUN i kombination med strålebehandling ved nyligt diagnoseret glioblastom
English: Sodium starch glycolate (Type B) Tartaric acid
Danish: Natriumstivelsesglycolat (type B) Vinsyre
English: Temozolomide SUN is at first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
Danish: Temozolomide SUN anvendes i starten sammen med strålebehandling (konkomiterende fase af behandling) og derefter alene (monoterapifase af behandling).
English: If a capsule is damaged, avoid contact with your skin, eyes or nose.
Danish: Hvis en kapsel beskadiges, skal du undgå kontakt med hud, øjne og næse.
English: a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting).
Danish: a: Behandling med konkomitant TMZ kan fortsættes, når alle de følgende betingelser er opfyldt: Absolut antal neutrofile ≥ 1,5 x 109/l; trombocyttal ≥ 100 x 109/l; CTC ikke hæmatologisk toksicitet ≤ Grad 1 (undtagen for alopeci, kvalme, opkastning).
English: Patients who have experienced severe (Grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy.
Danish: Patienter med tilbagevendende eller progressivt malignt gliom Patienter, der har haft alvorlige (grad 3 eller 4) opkastninger i tidligere behandlingsserier, kan have behov for antiemetisk behandling.
English: Pneumocystis jiroveciipneumonia
Danish: Pneumocystis jirovecii-lungebetændelse
English: Ask your doctor or pharmacist to write it down (including the marking) - which days are your dosing days.
Danish: (inklusive mærket) - de dage, der er dine doseringsdage.
English: Titanium dioxide (E171) Sodium laurilsulfate
Danish: Titaniumdioxid (E171) Natriumlaurilsulfat
English: Patients usually present with shortness of breath and cough.
Danish: Patienter har ofte kortåndethed og hoste.
English: See package leaflet for further information.
Danish: Pakningsstørrelser og yderligere oplysninger
English: Anti-emetic prophylaxis is recommended prior to the initial dose of concomitant phase and it is strongly recommended during the monotherapy phase.
Danish: Voksne patienter med nydiagnosticeret glioblastoma multiforme Antiemetisk forebyggelse anbefales før den initiale dosis af den konkomitante fase, og det anbefales kraftigt under monoterapi fasen.
English: In a study of 288 subjects with newly-diagnosed glioblastoma multiforme, Grade 4 neutropenia occurred in 3 % of female vs 0 % of male subjects and Grade 4 thrombocytopenia in 1 % of female vs 0 % of male subjects in the first cycle of therapy.
Danish: I en undersøgelse med 288 forsøgspersoner med nyligt diagnosticeret multiform glioblastom forekom Grad 4neutropeni hos 3 % af de kvindelige vs. 0 % af de mandlige forsøgspersoner og Grad 4thrombocytopeni hos 1 % af de kvindelige vs. 0 % af de mandlige forsøgspersoner i det første terapiforløb.
English: Patients who received concomitant TMZ and RT in a pilot trial for the prolonged 42-day schedule were shown to be at particular risk for developing Pneumocystis jirovecii pneumonia (PCP).
Danish: Patienter, som fik konkomitant TMZ og strålebehandling i en pilotundersøgelse af det længerevarende 42 dages-program, viste sig at have særlig risiko for at udvikle Pneumocystis jirovecii lungebetændelse (PCP).
English: Ear and labyrinth disorders Common:
Danish: Øre og labyrint Almindelige:
English: Uncommon (may affect up to 1 in 100 people): reduced blood cell counts (pancytopenia, anaemia, leukopenia).
Danish: Ikke almindelig (kan påvirke op til 1 ud af 100): reduceret antal blodlegemer (pancytopeni, anæmi,
English: - thrombocyte count ≥ 100 x 109/l
Danish: - trombocyttal ≥ 100 x 109/l
English: - in children 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma.
Danish: - hos børn i alderen 3 år og ældre og voksne patienter med malignant (ondartet) glioma, f.eks. glioblastoma multiforme eller anaplastisk astrocytom.
English: Skin exfoliation, photosensitivity reaction, pigmentation abnormal
Danish: Hudeksfoliering, lysoverfølsomhedsreaktion, unormal pigmentering
English: If a capsule becomes damaged, contact of the powder contents with skin or mucous membrane must be avoided.
Danish: Hvis en kapsel bliver beskadiget, skal kontakt mellem pulverindholdet og hud eller slimhinder undgås.
English: In patients previously untreated with chemotherapy, TMZ is administered orally at a dose of 200 mg/m2 once daily for the first 5 days followed by a 23 day treatment interruption (total of 28 days).
Danish: Til patienter, som ikke tidligere er behandlet med kemoterapi, indgives TMZ oralt i en dosis på 200 mg/m2 én gang dagligt i de første 5 dage efterfulgt af en 23dages behandlingspause (i alt 28 dage).
English: TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ Toxicity
Danish: TMZ-doseringsafbrydelse eller seponering under konkomitant strålebehandling og TMZ Toksicitet
English: Very common (may affect more than 1 in 10 people): reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia), loss of appetite, headache, vomiting, nausea (feeling sick), constipation (difficulty passing stools), tiredness.
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10): reduceret antal blodlegemer (neutropeni eller lymfopeni, trombocytopeni), manglende appetit, hovedpine, opkastning, kvalme (utilpashed), forstoppelse (afføringsbesvær), træthed.
English: In patients previously treated with chemotherapy, the initial dose is 150 mg/m2 once daily, to be increased in the second cycle to 200 mg/m2 once daily, for 5 days if there is no haematological toxicity (see section 4.4) Special populations
Danish: Til patienter, som tidligere er behandlet med kemoterapeutika, er den initiale dosis 150 mg/m2 én gang dagligt stigende i den anden serie til 200 mg/m2 én gang dagligt i 5 dage, såfremt der ikke er hæmatologisk toksicitet (se pkt.
English: Other medicines and Temozolomide SUN
Danish: Brug af anden medicin sammen med Temozolomide SUN
English: If you have been previously treated with chemotherapy, your first dose of Temozolomide SUN will be 150 mg/m2 once daily for the first 5 days.
Danish: Hvis du tidligere har været i kemoterapi, vil din første dosis af Temozolomide SUN være 150 mg/m2 én gang dagligt i de første 5 dage.
English: If you have not been previously treated with chemotherapy, your first dose of Temozolomide SUN will be 200 mg/m2 once daily for the first 5 days.
Danish: Hvis du ikke tidligere har været i kemoterapi, vil din første dosis af Temozolomide SUN være 200 mg/m2 én gang dagligt i de første 5 dage.
English: Keep this medicine out of the sight and reach of children, preferably in a locked cupboard.
Danish: Opbevar lægemidlet utilgængeligt for børn, helst i et låst skab.
English: Cases of increased bilirubin, problems with bile flow (cholestasis), hepatitis and injury to the liver, including fatal liver failure, have been uncommonly reported.
Danish: Der er rapporteret tilfælde af forhøjet bilirubin, problemer med ophobning af galde (kolestase), hepatitis (leverbetændelse) og leverskade, herunder dødeligt leversvigt med hyppigheden ”ikke almindelig”.
English: Nervous system disorders Very common:
Danish: Nervesystemet Meget almindelige:
English: Temozolomide SUN is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
Danish: Temozolomide SUN er indiceret til behandling af: - voksne patienter med nydiagnosticeret glioblastoma multiforme konkomitant med strålebehandling og herefter som monoterapi-behandling.
English: Patients receiving Temozolomide SUN in combination with radiotherapy may experience different side effects from patients taking Temozolomide SUN alone.
Danish: Patienter, der får Temozolomide SUN i kombination med strålebehandling, kan få andre bivirkninger end patienter, der kun tager Temozolomide SUN. Følgende bivirkninger kan forekomme og kan kræve medicinsk behandling.
English: Summary of events reported with temozolomide in the post-marketing setting*
Danish: Opsummering af bivirkninger, der er indberettet med temozolomid efter markedsføring
English: TMZ is administered orally at a dose of 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions).
Danish: Konkomitant fase TMZ indgives oralt i en dosis på 75 mg/m2 dagligt i 42 dage konkomitant med fokal strålebehandling (60 Gy indgivet i 30 fraktioner).
English: Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
Danish: Tabel 4 anfører bivirkninger fremkommet hos patienter med nydiagnosticeret glioblastoma multiforme under konkomitant- og monoterapi behandlingsfaserne.
English: Pneumocystis jiroveciipneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Danish: Pneumocystis jirovecii pneumoni (PCP) forebyggende behandling var påkrævet under strålebehandling og konkomitant TMZ behandling.
English: CTC Grade 4b a: TMZ dose levels are listed in Table 2. b: TMZ is to be discontinued if: - dose level -1 (100 mg/m2) still results in unacceptable toxicity
Danish: CTC Grad 4b a: TMZ dosistrin er anført i Tabel 2. b: TMZ skal seponeres, hvis:
English: Agitation, apathy, behaviour disorder, depression, hallucination
Danish: Uro, apati, ændret opførsel, depression, hallucination
English: Do not use this medicine after the expiry date which is stated on the label and carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel eller affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma A treatment cycle comprises 28 days.
Danish: Voksne og børn fra 3 år med tilbagevendende eller progressivt malignt gliom: En behandlingsserie består af 28 dage.
English: Hypokalemia, alkaline phosphatase increased, weight increased
Danish: Hypokalæmi, forhøjet alkalisk fosfatase,
English: - the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
Danish: • den samme Grad 3 ikke-hæmatologisk toksicitet (undtagen for alopeci, kvalme, opkastning) vender tilbage efter dosisreduktion.
English: Do not throw away any medicines via wastewater or household waste.
Danish: Lægemidler må ikke smides i afløbet, toilettet eller skraldespanden.
English: Psychiatric disorders Common:
Danish: Psykiske forstyrrelser Almindelige:
English: Infections and infestations Common:
Danish: Infektioner og parasitære sygdomme Almindelige:
English: Temozolomide SUN monotherapy in recurrent or progressive glioma
Danish: Monoterapi med Temozolomide SUN ved tilbagevendende eller fremskreden gliom
English: Blood and lymphatic system disorders Very common:
Danish: Blod og lymfesystem Meget almindelige:
English: Neutropenia, thrombocytopenia, lymphopenia, leukopenia
Danish: Neutropeni, thrombocytopeni, lymfopeni, leukopeni
English: Hemianopia, visual acuity reduced, vision disorder, visual field defect, eye pain
Danish: Hemianopi, nedsat synsskarphed, synslidelse, synsfeltdefekt, øjensmerte
English: Skin and subcutaneous tissue disorders Very common:
Danish: Hud og subkutane væv Meget almindelige:
English: The cap is imprinted with ‘930'.
Danish: Hætten er påtrykt med '930'.
English: Very rare (may affect up to 1 in 10,000 people): skin redness, urticaria (hives), skin eruption,
Danish: Meget sjælden (kan påvirke op til 1 ud af 10.000): rødme i huden, urticaria (nældefeber),
English: The cap is imprinted with ‘929'.
Danish: Hætten er påtrykt med '929'.
English: Excipient with known effect Each hard capsule contains 163.441 mg of lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hårde kapsel indeholder 163,441 mg lactose.
English: Patients with newly-diagnosed glioblastoma multiforme
Danish: Patienter med nyligt diagnosticerede glioblastoma multiforme
English: Excipient with known effect Each hard capsule contains 127.121 mg of lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hårde kapsel indeholder 127,121 mg lactose.
English: Do not open, crush or chew the capsules, swallow whole.
Danish: Kapslerne må ikke åbnes, knuses eller tygges, men skal sluges hele.
English: Excipient with known effect Each hard capsule contains 30.97 mg of lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hårde kapsel indeholder 30,97 mg lactose.
English: Blood and lymphatic system disorders Common:
Danish: Blod og lymfesystem Almindelige:
English: Excipient with known effect Each hard capsule contains 18.16 mg of lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hårde kapsel indeholder 18,16 mg lactose.
English: TMZ dose levels for monotherapy treatment Dose level
Danish: TMZ dosistrin for monoterapi-behandling
English: Renal and urinary disorders Common:
Danish: Nyrer og urinveje Almindelige:
English: Excipient with known effect Each hard capsule contains 90.801 mg of lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hårde kapsel indeholder 90,801 mg lactose.
English: Skin and subcutaneous tissue disorders Common:
Danish: Hud og subkutane væv Almindelige:
English: Excipient with known effect Each hard capsule contains 227.001 mg of lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hårde kapsel indeholder 227,001 mg lactose.
English: CTC non-haematological Toxicity (except for alopecia, nausea, vomiting)
Danish: CTC ikke-hæmatologisk toksicitet (undtagen for alopeci, kvalme, opkastning)
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS), peripheral neuropathy
Danish: Status epilepticus, ekstrapyramidal lidelse, hemiparese, ataksi, nedsat cognition, dysfasi, unormal gang, hyperesthesia, hypoesthesia, neurologisk lidelse (NOS), perifer neuropati
English: Gamma GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT.
Danish: AST *En patient, der kun var randomiseret til strålebehandlingsgruppen, fik TMZ + strålebehandling.
English: Hyperglycaemia, weight increased
Danish: Hyperglycæmi, vægtøgning vægtøgning