natgillin/translations-raw huggingface dataset:
I den store hovedundersøgelse med CML i kronisk fase virkede behandlingen hos 90% af patienterne, således at blodets indhold af blodplader og hvide blodlegemer igen blev normalt.
In the larger main study of patients with chronic phase CML, 90% of the patients responded to treatment, with blood levels of platelets and white blood cells returning to within predefined, normal values.
Hos patienter med CML i andre faser (accelereret, myeloid blastfase og lymfoid blastfase) og hos patienter med ALL opnåedes komplet bedring hos mellem en fjerdedel og en tredjedel af patienterne.
In patients with CML in other phases (accelerated, myeloid blast and lymphoid blast) and in ALL, between a quarter and a third of patients showed a complete response.
Desuden mindske - des antallet af hvide blodlegemer med Philadelphia- kromosomet hos mellem en tredjedel og to tredje - dele af patienterne i de fem hovedundersøgelser.
In addition, between one and two thirds of the patients in the five main trials showed a reduction in the number of white blood cells containing the Philadelphia chromosome.
Selvom virkningen af Sprycel i den yderligere undersøgelse af patienter med CML i kronisk fase stort set var den samme, når lægemidlet blev taget henholdsvis en og to gange dagligt, gav dosen taget en gang dagligt dog færre bivirkninger.
In the additional study of patients with chronic phase CML, although once- and twice-daily Sprycel had similar rates of effectiveness, the once-daily dose caused fewer side effects.
I undersøgelsen med patienter med fremskreden fase CML eller Ph+ ALL var responsen målt ud fra antallet af blodlegemer også nogenlunde den samme, hvad enten lægemidlet blev taget en eller to gange dagligt.
In the study of patients with advanced phase CML or Ph+ ALL, the response in terms of blood counts was also similar with once- and twice-daily Sprycel.
Dog responderede de patienter, som fik Sprycel to gange dagligt, længere end dem, der fik det en gang dagligt.
However, patients taking Sprycel twice a day continued to respond to the medicine for longer than those taking it once a day.
I undersøgelserne var de hyppigste bivirkninger ved Sprycel (der optræder hos flere end 1 ud af 10 patienter) hovedpine, pleural effusion (væske omkring lungerne), dyspnø (stakåndethed), hoste, diarré, kvalme, opkastning, mavepine, hududslæt, muskel - og ledsmerter, betændelse, blødninger, overfladisk ødem (hævelse), træthed, feber, neutropeni (lavt antal hvide blodlegemer), trombocytopeni (lavt antal blodplader og anæmi (lavt antal røde blodlegemer).
In studies, the most common side effects with Sprycel (seen in more than 1 patient in 10) were headache, pleural effusion (fluid around the lungs), dyspnoea (shortness of breath), cough, diarrhoea, nausea (feeling sick), vomiting, abdominal (tummy) pain, skin rash, musculoskeletal pain (pain in the joints and muscles), infection, haemorrhage (bleeding), superficial oedema (swelling), fatigue (tiredness), pyrexia (fever), neutropenia (low white blood cell counts), thrombocytopenia (low blood platelet counts) and anaemia (low red blood cell counts).
Den fuldstændige liste over de indberettede bi - virkninger for Sprycel fremgår af indlægssedlen.
For the full list of all side effects reported with Sprycel, see the Package Leaflet.
Sprycel bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for dasatinib eller andre af indholdsstofferne.
Sprycel should not be used in people who may be hypersensitive (allergic) to dasatinib or any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Sprycel opvejer risiciene til behandling af voksne patienter med kronisk eller accelereret CML eller CML i blastfasen samt til behandling af voksne patienter med Ph+ ALL og lymfoid blast- CML, hvor forudgående be - handling ikke virker eller ikke tåles.
The Committee for Medicinal Products for Human Use (CHMP) decided that Sprycel’ s benefits are greater than its risks for the treatment of adults with chronic, accelerated or blast phase CML, and for the treatment of adults with Ph+ ALL and lymphoid blast CML, with resistance or intolerance to prior therapy.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Sprycel.
The Committee recommended that Sprycel be given marketing authorisation.
2/ 3 Andre oplysninger om Sprycel:
Other information about Sprycel:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sprycel til Bristol- Myers Squibb Pharma EEIG den 20. november 2006.
The European Commission granted a marketing authorisation valid throughout the European Union for Sprycel to Bristol-Myers Squibb Pharma EEIG on 20 November 2006.
Sammendragene af udtalelserne fra Udvalget for Lægemidler til Sjældne Sygdomme findes her (CML) og her (ALL).
2/ 3 The summaries of opinion of the Committee for Orphan Medicinal Products for Sprycel are available here (CML) and here (ALL).
Den fuldstændige EPAR for Sprycel findes her.
The full EPAR for Sprycel can be found here.
Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Beholder (HDPE) Beholder (HDPE) Beholder (HDPE) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Beholder (HDPE) Blister (alu/ alu)
bottle (HDPE) bottle (HDPE) bottle (HDPE) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) bottle (HDPE) blister (alu/ alu)
60 tabletter 60 tabletter 60 tabletter 56 tabletter 56 tabletter 56 tabletter 60 x 1 tablet 60 x 1 tablet 60 x 1 tablet 30 tabletter 30 x 1 tablet
60 tablets 60 tablets 60 tablets 56 tablets 56 tablets 56 tablets 60 x 1 tablets (unit dose) 60 x 1 tablets (unit dose) 60 x 1 tablets (unit dose) 30 tablets 30 x 1 tablets (unit dose)
Hjælpestof: hver tablet indeholder 27 mg lactosemonohydrat.
Excipients: each tablet contains 27 mg of lactose monohydrate.
Hvide til gråligt hvide, bikonvekse, runde tabletter med "BMS" printet på den ene side og "527" på den anden.
White to off-white, biconvex, round tablet with "BMS" debossed on one side and "527" on the other side.
SPRYCEL er indiceret til behandling af voksne med kronisk, accelereret eller blastfase myeloid leukæmi (CML), som er resistente eller intolerante over for tidligere behandling, inklusive imatinibmesilat.
SPRYCEL is indicated for the treatment of adults with chronic, accelerated or blast phase chronic myeloid leukaemia (CML) with resistance or intolerance to prior therapy including imatinib mesilate.
SPRYCEL er også indiceret til behandling af voksne med Philadelphia- kromosompositiv (Ph+) akut lymfoblastær leukæmi (ALL) og CML i lymfoid blastfase med resistens eller intolerance over for tidligere behandling.
SPRYCEL is also indicated for the treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.
4. 4).
The recommended starting dose for chronic phase CML is 100 mg dasatinib once daily, administered orally, consistently either in the morning or in the evening (see section 4.4).
Dosis indtages som 1 tablet om morgenen og 1 tablet om aftenen.
The recommended starting dose for accelerated, myeloid or lymphoid blast phase (advanced phase) CML or Ph+ALL is 70 mg twice daily administered orally, one tablet in the morning and one in the evening.
Tabletterne må ikke knuses eller deles, men skal synkes hele.
Tablets must not be crushed or cut, they must be swallowed whole.
Varighed af behandling: i kliniske forsøg er behandling med SPRYCEL fortsat indtil sygdomsprogression, eller indtil patienten ikke længere tålte behandlingen.
Treatment duration: in clinical trials, treatment with SPRYCEL was continued until disease progression or until no longer tolerated by the patient.
Effekt af seponering af behandling, efter der er opnået fuldstændig cytogenetisk respons (CCyR), er ikke undersøgt.
The effect of stopping treatment after the achievement of a complete cytogenetic response (CCyR) has not been investigated.
SPRYCEL findes som 20 mg, 50 mg, 70 mg og 100 mg filmovertrukne tabletter for at opnå den anbefalede dosis.
To achieve the recommended dose, SPRYCEL is available as 20 mg, 50 mg, 70 mg and 100 mg film- coated tablets.
Stigning eller reduktion i dosis anbefales på baggrund af patientens respons og tolerabilitet.
Dose increase or reduction is recommended based on patient response and tolerability.
2 Dosistitrering:
2 Dose escalation:
I kliniske forsøg med voksne CML - og Ph+ ALL- patienter var dosistitrering til 140 mg 1 gang dagligt (CML i kronisk fase) eller 100 mg 2 gange dagligt (fremskreden CML eller Ph+ ALL) tilladt hos patienter, som ikke opnåede hæmatologisk eller cytogenetisk respons ved den anbefalede startdosis.
In clinical trials of adult CML and Ph+ ALL patients, dose escalation to 140 mg once daily (chronic phase CML) or 100 mg twice daily (advanced phase CML or Ph+ ALL) was allowed in patients who did not achieve a haematologic or cytogenetic response at the recommended starting dose.
Dosisjustering ved uønskede hændelser:
Dose adjustment for undesirable effects:
I kliniske forsøg er myelosuppression blevet behandlet med dosisafbrydelse, dosisreduktion eller seponering af forsøgsbehandling.
In clinical trials, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study therapy.
Hos patienter med resistent myelosuppression anvendtes hæmatopoetisk vækstfaktor.
Haematopoetic growth factor has been used in patients with resistant myelosuppression.
Retningslinier for dosisændringer er opsummeret i Tabel 1.
Guidelines for dose modifications are summarized in Table 1.
Dosisjusteringer ved neutropeni og trombocytopeni
Dose adjustments for neutropenia and thrombocytopenia
1 Stop behandling indtil ANC ≥ 1, 0 x 109/ l og trombocytter ≥ 50 x 109/ l.
1 Stop treatment until ANC ≥ 1.0 x 109/ l and platelets ≥ 50 x 109/ l.
2 Genoptag behandling ved den oprindelige startdosis.
Chronic Phase CML
CML i kronisk fase (startdosis 100 mg 1 gang dagligt)
(starting dose 100 mg once daily)
ANC < 0, 5 x 109/ l og/ eller trombocytter < 50 x 109/ l
and/ or Platelets < 50 x 109/ l
Ved trombocytter < 25 x 109/ l og/ eller recidiv af ANC < 0, 5 x 109/ l i > 7 dage, gentages trin 1 og genoptag behandling ved reduceret dosis 80 mg 1 gang dagligt (anden episode) eller seponering (tredje episode).
If platelets < 25 x 109/ l and/ or recurrence of ANC < 0.5 x 109/l for > 7 days, repeat step 1 and resume treatment at a reduced dose of 80 mg once daily (second episode) or discontinue (third episode).
1 Undersøg om cytopeni er relateret til leukæmi (marvaspirat eller biopsi).
Check if cytopenia is related to leukaemia (marrow aspirate or biopsy).
2 Hvis cytopeni ikke er relateret til leukæmi stoppes behandlingen, indtil ANC ≥ 1, 0 x 109/ l og trombocytter ≥ 20 x 109/ l og genoptages ved den oprindelige startdosis.
2 If cytopenia is unrelated to leukaemia, stop treatment until ANC ≥ 1.0 x 109/ l and platelets ≥ 20 x 109/ l and resume at the original starting dose.
Accelereret og blastfase ANC < 0, 5 x 109/ l CML og Ph+ ALL (startdosis 70 mg 2 gange
Accelerated and Blast Phase ANC < 0.5 x 109/ l CML and Ph+ ALL (starting dose 70 mg twice
og/ eller
and/ or
Hvis cytopeni recidiverer, gentages trin
If recurrence of cytopenia, repeat step 1
trombocytter < 10 x 109/ l
Platelets < 10 x 109/ l
1, og behandlingen genoptages ved reduceret dosis på 50 mg 2 gange dagligt (anden episode) eller 40 mg 2 gange dagligt (tredje episode).
and resume treatment at a reduced dose of 50 mg twice daily (second episode) or 40 mg twice daily (third episode).
Hvis cytopeni er relateret til leukæmi, skal dosiseskalering til 100 mg 2 gange dagligt, overvejes.
If cytopenia is related to leukaemia, consider dose escalation to 100 mg twice daily.
Ikke- hæmatologiske uønskede reaktioner:
Non-haematological adverse reactions:
Hvis der udvikles ikke- hæmatologiske uønskede reaktioner med dasatinib, afbrydes behandlingen, indtil hændelsen er svundet.
If a severe non-haematological adverse reaction develops with dasatinib, treatment must be withheld until the event has resolved.
Herefter genoptages behandlingen, eventuelt ved reduceret dosis, afhængigt af hændelsens initiale sværhedsgrad.
Thereafter, treatment can be resumed as appropriate at a reduced dose depending on the initial severity of the event.
3 Brug til børn:
Paediatric patients:
5. 1.).
SPRYCEL is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy (see section 5.1).
Brug til ældre: der er ikke observeret klinisk relevante, aldersrelaterede, farmakokinetiske forskelle hos disse patienter.
Elderly patients: no clinically relevant age-related pharmacokinetic differences have been observed in these patients.
Specifikke dosisanbefalinger for ældre er ikke nødvendige.
No specific dose recommendation is necessary in the elderly.
Leverinsufficiens: der er ikke gennemført kliniske forsøg med SPRYCEL med patienter med moderat til svært nedsat leverfunktion (patienter med ALAT og/ eller ASAT > 2, 5 gange den øvre normalgrænse og/ eller total- bilirubin > 2 gange den øvre normalgrænse blev ekskluderet i forsøgene).
3 Hepatic impairment: no clinical trials were conducted with SPRYCEL in patients with moderate to severe hepatic impairment (trials excluded patients with ALT and/ or AST > 2.5 times the upper limit of the normal range and/ or total bilirubin > 2 times the upper limit of the normal range).
Da dasatinib primært metaboliseres i leveren, forventes optagelsen af dasatinib at øges, hvis leverfunktionen er nedsat.
Since dasatinib is mainly metabolised through the liver, exposure to dasatinib is expected to increase if liver function is impaired.
4. 4).
SPRYCEL should be used with caution in patients with moderate to severe hepatic impairment (see section 4.4).
Nyreinsufficiens: der er ikke gennemført kliniske forsøg med SPRYCEL til patienter med nedsat nyrefunktion (patienter med en serum- creatininkoncentration > 1, 5 gange den øvre normalgrænse blev ekskluderet i forsøgene).
Renal impairment: no clinical trials were conducted with SPRYCEL in patients with decreased renal function (trials excluded patients with serum creatinine concentration > 1.5 times the upper limit of the normal range).
Da dasatinib og dets metabolitter har en nyreclearance < 4%, forventes total - clearance ikke at falde hos patienter med nyreinsufficiens.
Since the renal clearance of dasatinib and its metabolites is < 4%, a decrease in total body clearance is not expected in patients with renal insufficiency.
Klinisk relevante interaktioner Dasatinib er et substrat og en hæmmer af cytochrom P450 (CYP) 3A4.
Clinically relevant interactions Dasatinib is a substrate and an inhibitor of cytochrome P450 (CYP) 3A4.
4. 5).
Therefore, there is a potential for interaction with other concomitantly administered medicinal products that are metabolized primarily by or modulate the activity of CYP3A4 (see section 4.5).
Samtidig brug af dasatinib og lægemidler, der kan hæmme CYP3A4 (fx ketoconazol, itraconazol, erythromycin, clarithromycin, ritonavir, telithromycin) kan øge eksponeringen af dasatinib.
Concomitant use of dasatinib and medicinal products that potently inhibit CYP3A4 (e. g. ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, telithromycin) may increase exposure to dasatinib.
4. 5).
Therefore, in patients receiving dasatinib, coadministration of a potent CYP3A4 inhibitor is not recommended (see section 4.5).
Samtidig brug af dasatinib og lægemidler, der inducerer CYP3A4 (fx dexamethason, phenytoin, carbamazepin, rifampicin, phenobarbital eller naturlægemidler, der indeholder Hypericum perforatum, også kendt som prikbladet perikum) kan i betydelig grad reducere eksponeringen af dasatinib og dermed øge risikoen for behandlingssvigt.
John's Wort) may substantially reduce exposure to dasatinib, potentially increasing the risk of therapeutic failure.
4. 5).
Therefore, in patients receiving dasatinib, coadministration of alternative medicinal products with less potential for CYP3A4 induction should be selected (see section 4.5).
Samtidig brug af dasatinib og et CYP3A4- substrat kan øge eksponeringen af CYP3A4- substratet.
Concomitant use of dasatinib and a CYP3A4 substrate may increase exposure to the CYP3A4 substrate.
4. 5).
Therefore, caution is warranted when dasatinib is coadministered with CYP3A4 substrates of narrow therapeutic index, such as astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine) (see section 4.5).
Samtidig brug af dasatinib og en histamin- 2 (H2) - antagonist (fx famotidin), protonpumpe- hæmmer (fx omeprazol) eller aluminiumhydroxid/ magnesiumhydroxid kan reducere eksponeringen af dasatinib.
The concomitant use of dasatinib and a histamine-2 (H2) antagonist (e. g. famotidine), proton pump inhibitor (e. g. omeprazole), or aluminium hydroxide/ magnesium hydroxide may reduce the exposure to dasatinib.
4. 5).
Thus, H2 antagonists and proton pump inhibitors are not recommended and aluminium hydroxide/ magnesium hydroxide products should be administered up to 2 hours prior to, or 2 hours following the administration of dasatinib (see section 4.5).
Særlige patientgrupper Der foreligger aktuelt ingen data fra kliniske forsøg vedrørende SPRYCEL til patienter med moderat til svært nedsat leverfunktion.
Special populations There are currently no data available from clinical trials with SPRYCEL in patients with moderate to severe liver impairment.
4. 2).
Caution is recommended when administering SPRYCEL to patients with moderate to severe hepatic impairment (see section 4.2).
4 Vigtige uønskede reaktioner Myelosuppression:
Important adverse reactions Myelosuppression: treatment with dasatinib is associated with anaemia, neutropenia and thrombocytopenia.
Behandling med dasatinib er forbundet med anæmi, neutropeni og trombocytopeni.
Their occurrence is more frequent in patients with advanced phase CML or Ph+ ALL than in chronic phase CML.
Forekomsten er hyppigere hos patienter med CML eller Ph+ ALL i fremskreden fase end med CML i kronisk fase.
Complete blood counts should be performed weekly for the first 2 months, and then monthly thereafter, or as clinically indicated.
Der bør tages fuldstændigt blodbillede ugentligt i de første 2 måneder og herefter hver måned, eller som klinisk indiceret.
Myelosuppression was generally
Myelosuppression var almindeligvis reversibel og kunne oftest håndteres ved midlertidigt at afbryde dasatinib eller ved dosisreduktion (se pkt.
4 reversible and usually managed by withholding dasatinib temporarily or by dose reduction (see sections 4.2 and 4.8).
Væskeretention sås også oftere hos de patienter der blev behandlet 2 gange dagligt end hos de patienter der blev behandlet 1 gange dagligt (se pkt.
In a Phase III dose-optimisation study in patients with chronic phase CML, grade 3 or 4 myelosuppression was reported more frequently in patients treated with 70 mg twice daily than in patients treated with 100 mg once daily; fluid retention was also reported more frequently in patients treated with twice daily schedule compared to once daily (see section 4.8).
Til patienter med CML i kronisk fase anbefales derfor en startdosis på 100 mg 1 gang dagligt.
Therefore, the starting dose of 100 mg once daily is the recommended initial dose for patients with chronic phase CML.
I alle kliniske forsøg sås svær blødning i centralenervesystemet (CNS) hos < 1% af patienterne.
Bleeding: in all clinical studies, severe central nervous system (CNS) haemorrhage occurred in < 1% of patients.
Otte tilfælde var fatale, og 5 af disse var forbundet med trombocytopeni Common Toxicity Criteria (CTC) grad 4.
Eight cases were fatal and 5 of them were associated with Common Toxicity Criteria (CTC) grade 4 thrombocytopenia.
Der opstod svær gastrointestinal blødning hos 4% af patienterne, som almindeligvis krævede behandlingsafbrydelser og transfusioner.
Severe gastrointestinal haemorrhage occurred in 4% of patients and generally required treatment interruptions and transfusions.
2% af patienterne oplevede andre svære blødninger.
Other severe haemorrhage occurred in 2% of patients.
4. 8).
Most bleeding related events were typically associated with severe thrombocytopenia (see section 4.8).
Patienter, der fik lægemidler, der hæmmede trombocytfunktionen eller antikoagulantia, blev ekskluderet i kliniske forsøg med SPRYCEL.
Patients were excluded from participation in SPRYCEL clinical trials if they took medicinal products that inhibit platelet function or anticoagulants.
I nogle forsøg var brug af antikoagulantia, acetylsalicylsyre og non- steroide anti- inflammatoriske midler (NSAID) tilladt samtidig med SPRYCEL, hvis trombocyttallet var > 50. 000/ mm3.
In some trials, the use of anticoagulants, acetylsalicylic acid, and non-steroidal anti-inflammatory drugs (NSAIDs) was allowed concurrently with SPRYCEL 3 if the platelet count was > 50,000/ mm.
Væskeretention: dasatinib er forbundet med væskeretention.
Fluid retention: dasatinib is associated with fluid retention.
I alle kliniske forsøg sås svær væskeretention hos 9% af patienterne, inklusive svær pleural og perikardiel effusion, som blev indberettet hos henholdsvis 6% og 1% af patienterne.
In all clinical studies, severe fluid retention was reported in 9% of patients, including severe pleural and pericardial effusion reported in 6% and 1% of patients, respectively.
Svær ascites og generaliseret ødem blev hver især rapporteret hos < 1% af patienterne.
Severe ascites and generalised oedema were each reported in < 1% of patients.
Svær non- kardiogent lungeødem blev indberettet hos 1% af patienterne.
Severe non-cardiogenic pulmonary oedema was reported in 1% of patients.
Patienter som udvikler symptomer svarende til pleural effusion, fx dyspnø eller tør hoste, skal evalueres ved thorax- røntgen.
Patients who develop symptoms suggestive of pleural effusion such as dyspnoea or dry cough should be evaluated by chest X-ray.
Svær pleural effusion kan kræve thoracocentese og iltbehandling.
Severe pleural effusion may require thoracocentesis and oxygen therapy.
Væskeretentionshændelser håndteredes sædvanligvis ved understøttende tiltag der, omfatter diuretika og kortvarig behandling med steroider.
Fluid retention events were typically managed by supportive care measures that include diuretics and short courses of steroids.
4. 8).
While the safety profile of SPRYCEL in the elderly population was similar to that in the younger population, patients aged 65 years and older are more likely to experience fluid retention events and should be monitored closely (see section 4.8).
In vitro data tyder på, at dasatinib har potentiale til at forlænge kardiel ventrikulær repolarisering (QT- intervallet) (se pkt.
QT Prolongation: in vitro data suggest that dasatinib has the potential to prolong cardiac ventricular repolarization (QT Interval) (see section 5.3).
4. 8).
In 865 patients with leukaemia treated with dasatinib in Phase II clinical trials, the mean changes from baseline in QTc interval using Fridericia's method (QTcF) were 4 - 6 msec; the upper 95% confidence intervals for all mean changes from baseline were < 7 msec (see section 4.8).
Blandt de 2. 182 patienter som fik dasatinib i fase II/ III kliniske forsøg, blev QTc- forlængelse indberettet som bivirkning hos 18 patienter.
Of the 2,182 patients who received dasatinib in Phase II/ III clinical trials, 18 had QTc prolongation reported as an adverse event.
Sytten (< 1%) havde QTcF > 500msek.
Seventeen patients (< 1%) experienced a QTcF > 500 msec.