FrancophonIA/ELRC3.0 huggingface dataset:
English: Maternal body weight gains were reduced during gestation and lactation at ≥ 1 mg/kg/day but no maternal reproductive toxicity was observed up to 3 mg/kg/day (estimate exposure ≥ 2.3 times the AUC in patients administered the RDD).
Danish: Der sås reduktion af maternel vægstigning under drægtighed og diegivning ved >1 mg/kg/dag, men der sås ikke maternel reproduktionstoksisitet ved doser op til 3 mg/kg/dag (estimeret eksponering > 2,3 gange AUC hos patienter behandlet med ADD).
English: Population PK analyses of a pooled dataset from adult patients with GIST and solid tumours and paediatric patients with solid tumours were completed.
Danish: Der blev udført populationsfarmakokinetiske analyser af et puljet datasæt fra voksne patienter med GIST og solide tumorer, og pædiatriske patienter med solide tumorer.
English: Two patients (< 1%) who received sunitinib were diagnosed with CHF.
Danish: To patienter (<1%), som fik sunitinib, blev diagnosticeret med kronisk hjerteinsufficiens (CHF).
English: The most frequent adverse drug reactions were diarrhoea, nausea, WBC count decreased, neutropenia, and headache in 3 (50.0%) patients each, primarily Grade 1 or 2 in severity.
Danish: De hyppigste behandlingsrelaterede bivirkninger var diarré, kvalme, nedsat leukocyttal, neutropeni og hovedpine hos 3 (50,0 %) af patienterne primært af alvorlighedsgrad 1 eller 2.
English: Hypothyroidism was reported as an adverse reaction in 7 patients (4%) receiving sunitinib across the 2 cytokine-refractory MRCC studies; in 61 patients (16%) on sunitinib and 3 patients (< 1%) in the IFN- arm in the treatment-naïve MRCC study.
Danish: Hypotyreose er indberettet som en bivirkning hos 7 patienter (4%), som fik sunitinib i de 2 cytokinrefraktære mRCC-studier; hos 61 patienter (16%) på sunitinib og hos 3 patienter (<1%) i IFN-α-armen i det behandlingsnaive mRCC-studie.
English: In GIST patients ‘cardiac failure', ‘cardiac failure congestive', or ‘left ventricular failure' were reported in 1.2% of patients treated with sunitinib and 1% of patients treated with placebo.
Danish: ”Hjertesvigt”, ”kronisk venstresidig hjerteinsufficiens” eller ”venstre ventrikelsvigt” blev rapporteret hos 1,2% af GIST-patienterne, der blev behandlet med sunitinib, og hos 1% af patienterne, der blev behandlet med placebo.
English: • Musculoskeletal pain (pain in muscles and bones), muscular weakness, muscular fatigue, muscle pain, muscle spasms.
Danish: • Smerter i muskler og knogler, muskelsvaghed, muskeltræthed, muskelsmerter, muskelkramper.
English: Acquired hypothyroidism was noted in 6.2% of GIST patients on sunitinib versus 1% on placebo.
Danish: Erhvervet hypotyreose er set hos 6,2% af GIST-patienterne på sunitinib versus 1% på placebo.
English: Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered.
Danish: Anvendelse af anden samtidig medicin med ingen eller minimal mulighed for at inducere eller hæmme CYP3A4 bør overvejes.
English: Following oral administration in healthy volunteers, the elimination half-lives of sunitinib and its primary active desethyl metabolite are approximately 40-60 hours and 80-110 hours, respectively.
Danish: Hos raske forsøgspersoner er eliminationshalveringstiden af sunitinib og den aktive hovedmetabolit, desethylmetabolit, henholdsvis ca. 40-60 timer og 80-110 timer efter oral indtagelse.
English: Dose reductions occurred in 194 patients (52%) on sunitinib and 98 patients (27%) on IFN-α.
Danish: Dosis blev reduceret hos 194 patienter (52%) i sunitinib-behandling og hos 98 patienter (27%) i IFN-α-behandling.
English: Venous thromboembolic events were reported for 1 (1.2%) patient in the sunitinib arm and 5 (6.1%) patients in the placebo arm in the Phase 3 pNET study.
Danish: Venøse tromboemboliske hændelser blev rapporteret hos 1 (1,2%) patient i sunitinib-armen og hos 5 (6,1%) af patienterne i placeboarmen i pNET fase 3-studiet.
English: In treatment-naïve MRCC patients receiving IFN-, 6 (2%) venous thromboembolic events were reported; 1 patient (< 1%) experienced a Grade 3 DVT and 5 patients (1%) had pulmonary embolisms, all with Grade 4.
Danish: Hos de behandlingsnaive mRCC-patienter, der fik IFN-α, forekom 6 (2%) tromboemboliske hændelser; 1 patient (<1%) oplevede en grad 3 DVT, og 5 patienter (1%) fik lungeemboli, alle grad 4.
English: Seven hundred and fifty patients were randomised 1:1 to the treatment arms; they received treatment with either sunitinib in repeated 6-week cycles, consisting of 4 weeks of 50 mg daily oral administration followed by 2 weeks of rest (Schedule 4/2), or IFN-α, administered as a subcutaneous injection of 3 million units (MU) the first week, 6 MU the second week, and 9 MU the third week and thereafter, on 3 nonconsecutive days each week.
Danish: De fik behandling med enten sunitinib i en gentagen cyklus på 6 uger, bestående af 4 uger på 50 mg daglig oral administration, efterfulgt af 2 ugers pause (doseringsskema 4/2) eller IFN-α, administreret som en subkutan injektion 3 på hinanden ikke-følgende dage hver uge: 3 millioner enheder (MIE) den første uge, 6 MIE den anden uge og 9 MIE den tredje uge og herefter.
English: The most common adverse drug reactions were gastrointestinal (GI) toxicity, neutropenia, fatigue, and ALT elevation.
Danish: De hyppigste bivirkninger var gastrointestinal toksicitet, neutropeni, træthed og forhøjet niveau af ALAT.
English: Discontinue sunitinib in patients with nephrotic syndrome.
Danish: Behandling med sunitinib bør seponeres hos patienter med nefrotisk syndrom.
English: • Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Danish: • Smerter i munden, tænderne og/eller kæben, hævelse eller sår inde i munden, følelsesløshed eller tyngdefornemmelse i kæben, løse tænder.
English: Median OS in the ITT population was 72.7 weeks and 64.9 weeks (HR: 0.876; 95% CI: 0.679, 1.129; p=0.306), in the sunitinib and placebo arms, respectively.
Danish: Median OS i ITT-populationen var 72,7 uger og 64,9 uger (HR: 0,876; 95% CI: 0,679-1,129; p = 0,306) i henholdsvis sunitinib-armen og placebo-armen.
English: Administration of sunitinib with potent CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing St. John's Wort/Hypericum perforatum) may decrease sunitinib concentrations.
Danish: Administration af sunitinib sammen med potente CYP3A4-induktorer (f.eks. dexamethason, phenytoin, carbamazepin, rifampin, phenobarbital eller naturlægemidler som indeholder perikon/Hypericum perforatum) kan nedsætte koncentrationen af sunitinib.
English: Supportive care for gastrointestinal adverse reactions requiring treatment may include medicinal products with antiemetic, antidiarrhoeal, or antacid properties.
Danish: Disse gastrointestinale bivirkninger kan kræve understøttende behandling, som omfatter lægemidler med antiemetiske, obstiperende eller syreneutraliserende egenskaber.
English: If you have any questions about how Sutent works or why this medicine has been prescribed for you, ask your doctor.
Danish: Tal med din læge, hvis du har spørgsmål om, hvordan Sutent virker, eller hvorfor denne medicin er ordineret til dig.
English: • Tumour destruction leading to hole in the intestine (perforation).
Danish: • Nedbrydning af svulst, som kan give hul i tarmene (perforation).
English: The EMA has waived the obligation to submit the results of studies with Sutent in all subsets of the paediatric population for the treatment of kidney or renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma, and rhabdoid tumour of the kidney) (see section 4.2).
Danish: Det EMA har dispenseret fra kravet om at fremlægge resultaterne af studier med Sutent i alle undergrupper af den pædiatriske population ved behandling af nyre- eller nyrebækken-karcinom (eksklusive nefroblastom, nefroblastomatose, clear cell-sarkom, mesoblastisk nefrom, renalt medullært karcinom og rabdoid tumor i nyrerne) (se pkt.
English: No starting dose adjustment is required when administering sunitinib to patients with renal impairment (mild-severe) or with end-stage renal disease (ESRD) on haemodialysis.
Danish: Justering af initialdosis er ikke nødvendig, når sunitinib anvendes til patienter med nedsat nyrefunktion (mild-alvorlig) eller med nyresygdom i slutstadiet i hæmodialyse.
English: Anaemia has been observed to occur early as well as late during treatment with sunitinib.
Danish: Anæmi optræder både initialt og senere under behandlingen med sunitinib.
English: A pivotal Phase 3, multi-centre, international, randomised, double-blind, placebo-controlled study of single-agent sunitinib was conducted in patients with unresectable pNET.
Danish: Et pivotalt fase 3, multicenter, internationalt, randomiseret, dobbeltblindt, placebo-kontrolleret studie med monoterapi med sunitinib blev gennemført på patienter med inoperabel pNET.
English: Decreases in blood glucose, in some cases clinically symptomatic and requiring hospitalisation due to loss of consciousness, have been reported during sunitinib treatment.
Danish: Der er rapporteret fald i blodglucose under behandling med sunitinib, i nogle tilfælde med kliniske symptomer, som krævede hospitalsindlæggelse på grund af bevidstløshed.Ved symptomatisk hypoglykæmi skal sunitinib-behandlingen afbrydes midlertidigt.
English: • Painful skin ulceration (pyoderma gangrenosum).
Danish: • Smertefulde sår på huden (gangrænøs pyoderma).
English: Tell your doctor if you develop any of the following signs and symptoms of liver problems during Sutent treatment: itching, yellow eyes or skin, dark urine, and pain or discomfort in the right upper stomach area.
Danish: Fortæl det til lægen, hvis du får nogle af de følgende symptomer på leverproblemer under behandlingen med Sutent: kløe, gulfarvning af øjne eller hud, mørk urin, eller smerter og ubehag i den øvre højre side af maven.
English: One patient with pulmonary embolism in the cytokine-refractory MRCC study experienced dose interruption.
Danish: 1 patient med lungeemboli i studiet med cytokin-refraktære mRCC-patienter fik afbrudt behandlingen.
English: • Inflammation (swelling and redness) of the gallbladder with or without associated gallstones.
Danish: • Betændelse i galdeblæren med eller uden galdesten.
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelige: hos flere end 1 ud af 10 personer
English: Paediatric population Experience on the use of sunitinib in paediatric patients is limited (see section 4.2).
Danish: Pædiatrisk population Erfaringen med anvendelse af sunitinib hos pædiatriske patienter er begrænset (se pkt.
English: nausea, vomiting, diarrhoea, constipation, abdominal pain/swelling, loss/decrease of appetite.
Danish: kvalme, opkastning, diarré, forstoppelse, mavesmerter/udspiling af maven, nedsat appetit.
English: A clinically significant advantage in investigator-assessed PFS for sunitinib over placebo was observed.
Danish: Sunitinib viste en klinisk signifikant fordel i investigator-vurderet PFS i forhold til placebo.
English: The major active metabolite was not evaluated for genotoxic potential.
Danish: Den genotoksiske virkning af den aktive hovedmetabolit er ikke vurderet.
English: No starting dose adjustment is recommended when administering sunitinib to patients with mild or moderate (Child-Pugh class A and B) hepatic impairment.
Danish: Justering af initialdosis er ikke nødvendig, når sunitinib anvendes til patienter med mildt eller moderat nedsat leverfunktion (Child-Pugh klasse A og B).
English: The EMA has waived the obligation to submit the results of the studies with Sutent in all subsets of the paediatric population for the treatment of gastroenteropancreatic neuroendocrine tumours (excluding neuroblastoma, neuroganglioblastoma, and phaeochromocytoma) (see section 4.2).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Sutent i alle undergrupper af den pædiatriske population ved behandling af neuroendokrine gastroentero-pankreatiske tumorer (eksklusive neuroblastom, neuroganglioblastom og fæokromocytom (se pkt.
English: Reproductive and developmental toxicity
Danish: Reproduktionstoksicitet og udviklingstoksicitet
English: No formal clinical studies of the effect of sunitinib on wound healing have been conducted.
Danish: Der er ikke udført egentlige studier på sunitinib-behandlingens indflydelse på sårheling.
English: In healthy volunteers, concomitant administration of a single dose of sunitinib with the potent CYP3A4 inhibitor ketoconazole resulted in an increase of the combined [sunitinib + primary metabolite] maximum concentration (Cmax) and area under the curve (AUC0-) values of 49% and 51%, respectively.
Danish: Hos raske forsøgspersoner medførte samtidig administration af en enkeltdosis af sunitinib og den potente CYP3A4-hæmmer, ketoconazol, en stigning i samlet (sunitinib + primær metabolit) maksimal koncentration (Cmax) og arealet under kurven (AUC0-) værdi på henholdsvis 49% og 51%.
English: Risk factors associated with renal impairment/failure in patients receiving sunitinib included, in addition to underlying RCC, older age, diabetes mellitus, underlying renal impairment, cardiac failure, hypertension, sepsis, dehydration/hypovolaemia, and rhabdomyolysis.
Danish: Risikofaktorer relateret til nedsat nyrefunktion/nyresvigt hos patienter i behandling med sunitinib, udover underliggende RCC, omfatter høj alder, diabetes mellitus, underliggende nedsat nyrefunktion, hjertesvigt, hypertension, sepsis, dehydrering/hypovolæmi og Rabdomyolyse.
English: • Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, upset stomach,
Danish: • Mundsmerter/-irritation, mundsår/-betændelse/-tørhed, smagsforstyrrelser, mavebesvær,
English: Thyroid dysfunction
Danish: Thyroideadysfunktion
English: In the Phase 3 pNET study hypothyroidism was reported in 6 patients (7.2%) receiving sunitinib and in 1 patient (1.2%) on placebo.
Danish: I fase 3 pNET-studiet er der rapporteret om hypotyreose hos 6 patienter (7,2%), som fik sunitinib, og hos 1 patient (1,2%), som fik placebo.
English: Hypothyroidism has been observed to occur early as well as late during treatment with sunitinib (see section 4.8).
Danish: Hypotyreose kan opstå både tidligt og sent i behandlingen med sunitinib (se pkt.
English: Cases of serious pancreatic events, some with fatal outcome, have been reported.
Danish: Der er rapporteret om alvorlige tilfælde af pankreatitis, nogle letale.
English: Upon disease progression, patients were unblinded and placebo patients were offered access to open-label sunitinib in a separate extension study.
Danish: Ved sygdomsprogression blev randomiseringskoden brudt, og placebo-patienter fik tilbudt ublindet behandling med sunitinib i et særskilt forlængelsesstudie.
English: Treatment-related venous thromboembolic events were reported in patients who received sunitinib including deep venous thrombosis and pulmonary embolism (see section 4.8).
Danish: Behandlingsrelaterede venøse tromboemboliske hændelser er rapporteret hos patienter, som blev behandlet med sunitinib herunder dyb venetrombose og lungeemboli (se pkt.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne, som er angivet i pkt.
English: If angioedema due to hypersensitivity occurs, sunitinib treatment should be interrupted and standard medical care provided (see section 4.8).
Danish: Hvis der opstår angioødem på grund af overfølsomhed, afbrydes sunitinibbehandlingen, og standardbehandling iværksættes (se pkt.
English: - Pancreatic neuroendocrine tumours (pNET) (tumours of the hormone-producing cells in the pancreas) that have progressed or cannot be removed with surgery.
Danish: - Svulster i bugspytkirtlen (i de hormonproducerende celler) (pNET), som er fremadskreden eller ikke kan opereres
English: In clinical trials, decreases in left ventricular ejection fraction (LVEF) of  20% and below the lower limit of normal were reported in approximately 2% of sunitinib-treated GIST patients, 4% of cytokine-refractory MRCC patients, and 2% of placebo-treated GIST patients.
Danish: I kliniske studier forekom fald i venstre ventrikels ejektionsfraktion (LVEF) på  20% og under den nedre referenceværdi hos ca. 2% af sunitinib-behandlede GIST-patienter, hos 4% af cytokinrefraktære mRCC-patienter og hos 2% af placebobehandlede GIST-patienter.
English: Decreased absolute neutrophil counts of Grade 3 and 4 severities, respectively, were reported in 10% and 1.7% of patients on the Phase 3 GIST study, in 16% and 1.6% of patients on the Phase 3 MRCC study, and in 13% and 2.4% of patients on the Phase 3 pNET study.
Danish: Nedsat absolut neutrofiltal henholdsvis af sværhedsgrad 3 og 4 er rapporteret hos 10% og 1,7% af patienterne i fase 3 GIST-studiet, hos 16% og 1,6% af patienterne i fase 3 mRCC-studiet og hos 13% og 2,4% af patienterne i fase 3 pNET-studiet.
English: − GIST or MRCC: the usual dose is 50 mg once daily taken for 28 days (4 weeks), followed by 14 days (2 weeks) of rest (no medicine), in 6-week cycles.
Danish: • GIST eller kræft i nyrerne (MRCC), er den sædvanlige dosis 50 mg 1 gang dagligt i 28 dage (4 uger), efterfulgt af en pause på 14 dage (2 uger) (uden medicin).
English: In a 2-year rat carcinogenicity study (0, 0.33, 1, or 3 mg/kg/day), administration of sunitinib in 28-day cycles followed by 7-day dose-free periods resulted in increases in the incidence of phaeochromocytomas and hyperplasia in the adrenal medulla of male rats given 3 mg/kg/day following > 1 year of dosing (≥ 7.8 times the AUC in patients administered the RDD).
Danish: I et 2-års karcinogenicitetsstudier i rotter (0, 0,33, 1, eller 3 mg/kg/dag) resulterede administration af sunitinib i cykli på 28 dage efterfulgt af en 7-dages doseringsfri periode i en øgning af fæokromocytom og binyremarvhyperplasi hos hanrotter, der fik 3 mg/kg/dag efter > 1 års dosering (> 7,8 gange AUC hos patienter behandlet med ADD).
English: Cases of fistula formation, sometimes associated with tumour necrosis and regression, in some cases with fatal outcomes, have been reported (see section 4.4).
Danish: Der er rapporteret om tilfælde af fisteldannelse, i nogle tilfælde ledsaget af tumornekrose og regression, i nogle tilfælde med letal udgang (se pkt.
English: Left ventricular failure*
Danish: Venstre ventrikelsvigt Torsades de pointes
English: What Sutent is and what it is used for What you need to know before you take Sutent How to take Sutent
Danish: Virkning og anvendelse Det skal du vide før du begynder at tage Sutent Sådan skal du tage Sutent Bivirkninger
English: Tell your doctor if you feel very tired, are short of breath, or have swollen feet and ankles.
Danish: Fortæl det til lægen, hvis du føler dig meget træt, har vejtrækningsbesvær (stakåndethed) eller hævede ankler eller fødder.
English: Abbreviations: CI=confidence interval; N=number of patients; PFS=progression-free survival; pNET=pancreatic neuroendocrine tumours.
Danish: Forkortelser: CI=konfidensinterval; N=antal patienter; PFS=progressionsfri overlevelse; pNET= neuroendokrine tumorer i pancreas.
English: The median OS was 114.6 weeks for the sunitinib arm (95% CI: 100.1, 142.9) and 94.9 weeks for the IFN-α arm (95% CI: 77.7, 117.0) with a hazard ratio of 0.821 (95% CI: 0.673, 1.001; p=0.0510 by unstratified log-rank).
Danish: Median OS var 114,6 uger for sunitinib-armen (95% CI: 100,1-142,9) og 94,9 uger for IFN-α-armen (95% CI: 77,7-117,0) med hazard ratio 0,821 (95% CI: 0,673-1,001; p = 0,0510 ved ustratificeret logrank).
English: Aspartate aminotransferase increased Alanine aminotransferase increased Blood creatinine increased Blood pressure increased Blood uric acid increased
Danish: Nedsat antal hvide blodlegemer Forhøjet lipase Nedsat antal trombocytter Nedsat hæmoglobin Forhøjet amylase Forhøjet aspartataminotransferase Forhøjet alaninaminotransferase Forhøjet blodkreatinin
English: If you get any side effects, talk to your doctor.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge eller apoteket.
English: Decreased platelet counts of Grade 3 and 4 severities, respectively, were reported in 3.7% and 0.4% of patients on the Phase 3 GIST study, in 8.2% and 1.1% of patients on the Phase 3 MRCC study, and in 3.7% and 1.2% of patients on the Phase 3 pNET study (see section 4.4).
Danish: Nedsat trombocyttal af henholdsvis sværhedsgrad 3 og 4 er rappporteret hos 3,7% og 0,4 % af patienterne i fase 3-GIST-studiet, hos 8,2% og 1,1% af patienterne i fase 3 mRCC-studiet og hos 3,7% og 1,2% af patienterne i fase 3 pNET-studiet (se pkt.
English: Abbreviations: CI=confidence interval; ITT=intent-to-treat; NA=not applicable; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; TTP=time-to-tumour progression.
Danish: Forkortelser: CI=konfidensinterval; ITT=intent to treat; NA=ikke relevant; ORR=objektiv responsrate; OS=samlet overlevelse ; PFS= progressions-fri overlevelse; TTP=tidspunkt til tumorprogression.
English: Dose interruptions occurred in 202 patients (54%) on sunitinib and 141 patients (39%) on IFN-α.
Danish: Behandlingen blev afbrudt hos 202 patienter (54%) i sunitinib-behandling og hos 141 patienter (39%) i IFN-α-behandling.
English: Hypertension was reported in 26.5% of patients receiving sunitinib in a Phase 3 pNET study, compared to 4.9% of patients receiving placebo.
Danish: Hypertension blev rapporteret hos 26,5% af de patienter, som fik sunitinib i et fase 3 pNET-studie, og hos 4,9% af de patienter, der fik placebo.
English: If you are taking warfarin or acenocoumarole, medicines which thin the blood to prevent blood clots, there may be a greater risk of bleeding.
Danish: Hvis du tager blodfortyndende medicin som warfarin eller coumarin, har du en større risiko for blødninger.
English: • Burning or painful sensation in the tongue, inflammation of the digestive tract lining, excessive gas in the stomach or intestine.
Danish: • Brændende eller smertende fornemmelse i tungen, betændelseslignende reaktion i mave tarmkanalens slimhinde, for meget luft i maven eller tarmene.
English: In patients receiving sunitinib for treatment-naïve MRCC, 39% had bleeding events vs 11% of patients receiving interferon- (IFN-α).
Danish: 39% af de patienter, der fik sunitinib for tidligere ubehandlet mRCC, fik blødningsepisoder sammenlignet med 11% af de patienter, der fik interferon-α (IFN-α).
English: Temporary interruption of sunitinib therapy is recommended for precautionary reasons in patients undergoing major surgical procedures.
Danish: Af forsigtighedsmæssige årsager anbefales det at afbryde behandlingen med sunitinib midlertidigt hos patienter, der skal have foretaget større kirurgiske indgreb.
English: If symptoms of pancreatitis are present, patients should have sunitinib discontinued and be provided with appropriate supportive care.
Danish: Ved symptomer på pankreatitis, bør behandling med sunitinib seponeres, og patienterne bør have relevant medicinsk behandling.
English: At the time of the prespecified interim analysis, the median TTP on sunitinib was 28.9 weeks (95% CI: 21.3, 34.1) as assessed by the investigator and 27.3 weeks (95% CI: 16.0, 32.1) as assessed by the independent review and was statistically significantly longer than the TTP on placebo of 5.1 weeks (95% CI: 4.4, 10.1) as assessed by the investigator and 6.4 weeks (95% CI: 4.4, 10.0) as assessed by the independent review.
Danish: På tidspunktet for den forud specificerede interimanalyse var median-TTP for sunitinib 28,9 uger (95%CI = 21,3 - 34,1) baseret på investigators vurderinger og 27,3 uger (95% CI = 16,0 - 32,1) baseret på Independent Review Board, og den var statistisk signifikant længere end TTP for placebo på 5,1 uger (95% CI = 4,4 - 10,1 uger; p<0,001) baseret på investigators vurderinger og 6,4 uger (95% CI = 4,410,0S) baseret på Independent Review Board.