natgillin/translations-raw huggingface dataset:
I alt 173 patienter blev efterfølgende indskrevet i et udvidet forsøg, hvor patienterne fik 2 mg/kg elosulfase alfa hver uge eller 2 mg/kg hver anden uge, og dernæst blev alle ændret til 2 mg/kg hver uge, efter at resultaterne fra uge 24 var til rådighed.
A total of 173 patients subsequently enrolled in an extension trial in which patients received 2 mg/kg of elosulfase alfa every week or 2 mg/kg every other week, and then all were switched to 2 mg/kg every week upon availability of the Week 24 results.
I alt 18 % af patienterne havde tidligere haft psoriatisk artritis.
A total of 18% of patients had a history of psoriatic arthritis.
I alt 190 p atienter i alderen 1 måned til under 4 år er blevet behandlet med levetiracetam i p lacebokontrollerede og åbne, forlængede studier.
In patients aged 1 month to less than 4 years, a total of 190 patients have been treated with levetiracetam in placebo-controlled and open label extension studies.
I alt 197 patienter i alderen 15 år og derover med svær, aktiv granulomatose med polyangiitis (75%) eller mikroskopisk polyangiitis (24%) blev inkluderet og behandlet i et randomiseret, dobbeltblindet, placebokontrolleret, non-inferioritets-multicenterstudie med aktiv kontrolgruppe.
A total of 197 patients aged 15 years or older with severely, active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicenter, non-inferiority trial.
I alt 2.553 patienter var inkluderet i sikkerhedsanalysen af dabigatranetexilat i de to aktivt- kontrollerede DVT/LE-behandlingsstudier RE-COVER og RE-COVER II.
In the 2 active controlled a DVT/PE treatment trials, RE-COVER and RE-COVER II, a total of 2,553 patients were included in the safety analysis for dabigatran etexilate.
I alt 2.553 patienter var inkluderet i sikkerhedsanalysen af dabigatranetexilat i de to aktivt- kontrollerede DVT/LE-behandlingsstudier RE-COVER og RE-COVER II.
In the 2 active controlled DVT/PE treatment trials, RE-COVER and RE-COVER II, a total of 2,553 patients were included in the safety analysis for dabigatran etexilate.
I alt 2.626 patienter (58 % af kvinderne, der var inkluderet i forlængelsesstudiet, dvs.
A total of 2,626 subjects (58% of the women included in the extension study i.e.
I alt 2.928 patienter deltog i OSLER-2.
A total of 2928 patients enrolled in OSLER-2.
I alt 201 patienter med Cushings sygdom har fået Signifor i fase II- og III-studier.
A total of 201 Cushing’s disease patients received Signifor in phase II and III studies.
I alt 217 personer i alderen 18-65 år fik IXIARO sammen med inaktiveret rabiesvaccine (Rabipur) efter en hurtig immuniseringsplan på dag 0 og dag 7, og 56 forsøgspersoner fik IXIARO alene efter den konventionelle immuniseringsplan på dag 0 og dag 28.
A total of 217 subjects aged 18-65 years received IXIARO together with inactivated rabies vaccine (Rabipur) in a rapid immunisation schedule on Day 0 and Day 7 and 56 subjects received IXIARO alone in the conventional immunisation schedule on Day 0 and Day 28.
I alt 22 pædiatriske og unge patienter (i alderen 5 måneder til 17 år) fik Soliris i aHUS-studie C10-003.
A total of 22 paediatric and adolescents patients (aged 5 months to 17 years) received Soliris in aHUS Study C10-003.
I alt 225 patienter på ≥ 18 år med recidiveret eller refraktær B-prækursor-ALL blev eksponeret for BLINCYTO i kliniske studier.
A total of 225 patients aged ≥ 18 years of age with relapsed or refractory B-precursor ALL were exposed to BLINCYTO during clinical trials.
I alt 23/99 (23%) af de MabThera-behandlede patienter i studiet blev testet positive for HACA ved måned 18.
A total of 23/99 (23%) MabThera-treated patients in the trial tested positive for HACA by 18 months.
I alt 234 forsøgspersoner i alderen 1-17 år blev behandlet i et randomiseret, dobbelt-blindt, multi- center, placebokontrolleret klinisk studie med parallelle grupper.
A total of 234 subjects aged 1 to 17 years were treated in a randomized, double-blind, multi-centre, placebo controlled parallel group, dose ranging study.
I alt 235 patienter med MPS IVA blev rekrutteret og eksponeret for Vimizim i seks kliniske forsøg.
A total of 235 patients with MPS IVA were enrolled and exposed to Vimizim in six clinical trials.
I alt 246 ALK-positive NSCLC-patienter blev inkluderet og behandlet med en Zykadia-dosis på 750 mg: 163 havde tidligere fået behandling med en ALK-hæmmer og 83 var ALK-hæmmer behandlingsnaive.
A total of 246 ALK-positive NSCLC patients were enrolled who were treated at a Zykadia dose of 750 mg: 163 who had received prior treatment with an ALK inhibitor and 83 who were ALK inhibitor naïve.
I alt 257 patienter med type 2-diabetes deltog i et 24-ugers randomiseret, dobbeltblindt, placebokontrolleret studie til evaluering af saxagliptins sikkerhed og virkning (5 mg én gang dagligt) i kombination med metformin og sulfonylurinstof (SU) hos patienter med utilstrækkelig glykæmisk kontrol (HbA1c ≥ 7 % og ≤ 10 %).
A total of 257 patients with type 2 diabetes participated in a 24-week randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin (5 mg once daily) in combination with metformin plus sulphonylurea (SU) in patients with inadequate glycemic control (HbA1c ≥ 7% and ≤ 10%).
I alt 257 patienter med type 2-diabetes deltog i et 24-ugers randomiseret, dobbeltblindt, placebokontrolleret studie til evaluering af saxagliptins sikkerhed og virkning (5 mg én gang dagligt) i kombination med metformin og sulfonylurinstof hos patienter med utilstrækkelig glykæmisk kontrol (HbA1c ≥ 7 % og ≤ 10 %).
A total of 257 patients with type 2 diabetes participated in a 24-week randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin (5 mg once daily) in combination with metformin plus sulphonylurea (SU) in patients with inadequate glycemic control (HbA1c ≥ 7% and ≤ 10%).
I alt 270 patienter i aldersgruppen 65 år eller derover, inklusive 46 patienter i aldersgruppen 75 år eller derover, blev behandlet subkutant med abatacept i kontrollerede kliniske forsøg.
A total of 270 patients 65 years of age and older, including 46 patients 75 years and older, received subcutaneous abatacept in controlled clinical trials.
I alt 323 patienter i aldersgruppen 65 år eller derover, inklusive 53 patienter i aldersgruppen 75 år eller derover, blev behandlet intravenøst med abatacept i placebo-kontrollerede kliniske forsøg.
A total of 323 patients 65 years of age and older, including 53 patients 75 years and older, received intravenous abatacept in placebo-controlled clinical trials.
I alt 323 patienter i aldersgruppen 65 år eller derover, inklusive 53 patienter i aldersgruppen 75 år eller derover, blev behandlet med abatacept i placebo-kontrollerede kliniske forsøg.
A total of 323 patients 65 years of age and older, including 53 patients 75 years and older, received abatacept in placebo-controlled clinical trials.
I alt 33.357 hypertensive patienter på 55 år eller ældre blev randomiseret og fulgt i gennemsnitligt 4,9 år.
A total of 33,357 hypertensive patients aged 55 or older were randomised and followed for a mean of
I alt 345 interferon alfa-relaps patienter blev behandlet i to kliniske undersøgelser med IntronA monoterapi eller i kombination med ribavirin.
A total of 345 interferon alpha relapse patients were treated in two clinical trials with IntronA monotherapy or in combination with ribavirin.
I alt 347 stabile respondenter deltog i en evaluering af behandlingsafbrydelse og genbehandling i et åbent forlængelsesstudie.
A total of 347 stable responders participated in a withdrawal and retreatment evaluation in an open- label extension study.
I alt 366 patienter fik foretaget både testen med Pylobactell og en standardbiopsi (hvor en prøve fra maven analyseres for at se, om den er inficeret).
A total of 366 patients underwent both a Pylobactell test and a standard biopsy test (where a sample from the stomach is analysed to see if it is infected).
I alt 395 (46,7 %) af alle patienter var ikke evaluerbare for MMR efter 72 måneder (130 i nilotinib 300 mg to gange dagligt gruppen, 110 i nilotinib 400 mg to gange dagligt gruppen og 155 i imatinib- gruppen) på grund af manglende / ikke evaluerbare PCR-vurderinger (n=25), atypiske transkripter ved baseline (n=8) eller seponering forud for 72-måneders tidspunktet (n=362).
A total of 395 (46.7%) of all patients were not evaluable for MMR at 72 months (130 in the nilotinib 300 mg twice daily group, 110 in the nilotinib 400 mg twice daily group and 155 in the imatinib group) due to missing/unevaluable PCR assessments (n=25), atypical transcripts at baseline (n=8) or discontinuation prior to the 72-month time point (n=362).
I alt 4 patienter (1%), der blev behandlet med OZURDEX, gennemgik en operation i forsøgsøjet til behandling af forhøjet intraokulært tryk.
A total of 4 patients (1%) treated with OZURDEX had procedures in the study eye for the treatment of IOP elevation.
I alt 4.204 patienter blev behandlet med Taltz i kliniske udviklingsstudier med plaque-psoriasis.
A total of 4,204 patients were treated with Taltz in clinical development studies in plaque psoriasis.
I alt 4.550 kvinder (2.343 Prolia og 2.207 placebo), der manglede at få højst én dosis af studiemedicinen i det ovenfor beskrevne pivotale studie, og som gennemførte studiebesøget ved måned 36, indvilligede i at deltage i et 7-årigt, multinationalt, åbent multicenter-forlængelsesstudie med en enkelt behandlingsarm for at undersøge Prolias sikkerhed og virkning ved længerevarende behandling.
A total of 4,550 women (2,343 Prolia & 2,207 placebo) who missed no more than one dose of investigational product in the pivotal study described above and completed the month 36 study visit agreed to enrol in a 7-year, multinational, multicentre, open-label, single-arm extension study to evaluate the long-term safety and efficacy of Prolia.
I alt 405 patienter blev randomiseret til enten nivolumab (n = 272) 3 mg/kg hver 2. uge indgivet intravenøst over en periode på 60 minutter eller kemoterapi (n = 133), som bestod af investigators valg af enten dacarbazin (1000 mg/m2 hver 3. uge) eller carboplatin (AUC 6 hver 3. uge) og paclitaxel (175 mg/m2 hver 3. uge).
A total of 405 patients were randomised to receive either nivolumab (n = 272) administered intravenously over 60 minutes at 3 mg/kg every 2 weeks or chemotherapy (n = 133) which consisted of the investigator’s choice of either dacarbazine (1000 mg/m2 every 3 weeks) or carboplatin (AUC 6 every 3 weeks) and paclitaxel (175 mg/m2 every 3 weeks).
I alt 417 patienter blev randomiseret, 117 til ONIVYDE + 5-FU/LV-gruppen, 151 til ONIVYDE-monoterapigruppen og 149 til 5-FU/LV-gruppen.
A total of 417 patients were randomised to the ONIVYDE+5-FU/LV arm (N=117), ONIVYDE monotherapy arm (N=151) and 5-FU/LV arm (N=149).
I alt 418 patienter blev randomiseret til enten nivolumab (n = 210) 3 mg/kg hver 2. uge administreret intravenøst over 60 minutter eller dacarbazin (n = 208) 1000 mg/m2 hver 3. uge.
A total of 418 patients were randomised to receive either nivolumab (n = 210) administered intravenously over 60 minutes at 3 mg/kg every 2 weeks or dacarbazine (n = 208) at 1000 mg/m2 every 3 weeks.
I alt 43 % af patienterne i begge behandlingsgrupper havde tidligere fået strålebehandling.
A total of 43% of patients in both treatment groups had previously received radiotherapy.
I alt 455 patienter med type 2-diabetes deltog i et 24-ugers randomiseret, dobbeltblindt, placebokontrolleret studie til evaluering af saxagliptins sikkerhed og virkning i kombination med en stabil dosis insulin (gennemsnitlig baseline-værdi: 54,2 enheder) hos patienter med utilstrækkelig glykæmisk kontrol (HbA1c ≥ 7,5 % og ≤ 11 %) på insulin alene (n=141) eller på insulin i kombination med en stabil dosis metformin (n=314).
A total of 455 patients with type 2 diabetes participated in a 24-week randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin in combination with a stable dose of insulin (baseline mean: 54.2 Units) in patients with inadequate glycaemic control (HbA1c ≥ 7.5% and ≤ 11%) on insulin alone (n=141) or on insulin in combination with a stable dose of metformin (n=314).
I alt 46 dasatinib-behandlede patienter havde recidiverende pleuraeffusion.
A total of 46 dasatinib-treated patients had recurrent pleural effusions.
I alt 460 patienter (methylnaltrexonbromid 12 mg én gang daglig, n=150, methylnaltrexonbromid 12 mg hver anden dag, n=148, placebo, n=162) blev behandlet i den dobbeltblindede periode.
A total of 460 patients (methylnaltrexone bromide 12 mg once daily, n = 150, methylnaltrexone bromide 12 mg every other day, n = 148, placebo, n = 162) were treated in the double-blind period.
I alt 5.153 patienter blev randomiseret i de poolede RE-COVER og RE-COVER II-studier, og 5.107 patienter blev behandlet.
In the pooled RE-COVER and RE-COVER II studies, a total of 5,153 patients were randomized and 5,107 were treated.
I alt 52 tilfælde af invasiv sygdom forårsaget af vaccine serotyper var akkumuleret i en udvidet, blindet opfølgningsperiode indtil 20. april 1999.
A total of 52 cases of invasive disease caused by vaccine serotypes had accumulated in a blinded follow- up period through April 20, 1999.
I alt 534 voksne patienter med type 2-diabetes mellitus og utilstrækkelig glykæmisk kontrol på monoterapi med metformin (HbA1c ≥ 8 % og ≤ 12 %) deltog i dette randomiserede superioritetsstudie med aktiv kontrol af 24 ugers varighed, som sammenlignede kombinationen med saxagliptin og dapagliflozin som tillægsbehandling til metformin versus saxagliptin (DPP-4-hæmmer) eller dapagliflozin (SGLT2-hæmmer) som tillægsbehandling til metformin.
A total of 534 adult patients with type 2 diabetes mellitus and inadequate glycaemic control on metformin alone (HbA1c ≥ 8 % and ≤ 12 %), participated in this 24-week randomized, double-blind, active comparator-controlled superiority trial to compare the combination of saxagliptin and dapagliflozin added concurrently to metformin, versus saxagliptin (DPP-4 inhibitor) or dapagliflozin (SGLT2 inhibitor) added to metformin.
I alt 54 (39,7 %) patienter modtog behandling i > 12 måneder i olaparibgruppen sammenlignet med 14 (10,9 %) patienter i placebogruppen.
A total of 54 (39.7%) patients received treatment for > 12 months in the olaparib group compared with 14 (10.9%) patients in the placebo group.
I alt 55 patienter døde under behandlingen eller under followup efter behandlingsophør (21 i gruppen, der fik nilotinib 300 mg 2 gange dagligt, 11 i gruppen, der fik nilotinib 400 mg 2 gange dagligt, og 23 i gruppen, der fik imatinib 400 mg 1 gang dagligt).
A total of 55 patients died during treatment or during the follow-up after discontinuation of treatment. (21 in the nilotinib 300 mg twice daily group, 11 in the nilotinib 400 mg twice daily group and 23 in the imatinib 400 mg once daily group).
I alt 57 patienter ud af 673, hvis tumorer retrospektivt blev analyseret ved sekventering, havde BRAF- V600K-mutationspositivt melanom i NO25026.
A total of 57 patients out of 673 whose tumours were analysed retrospectively by sequencing were reported to have BRAF V600K mutation-positive melanoma in NO25026.
I alt 573 patienter med moderat til svæ r aktiv Crohns sygdom (CDAI ≥ 220 ≤ 400) fik en enkelt infusionsdosis på 5 mg/kg ved uge 0.
A total of 573 patients with moderately to severely active Crohn’s disease (CDAI ≥ 220 ≤ 400) received a single infusion of 5 mg/kg at week 0.
I alt 573 patienter med moderat til svær aktiv Crohns sygdom (CDAI ≥ 220 ≤ 400) fik en enkelt infusionsdosis på 5 mg/kg ved uge 0.
A total of 573 patients with moderately to severely active Crohn’s disease (CDAI ≥ 220 ≤ 400) received a single infusion of 5 mg/kg at week 0.
I alt 573 patienter med moderat til svært aktiv Crohns sygdom (CDAI ≥ 220 ≤ 400) fik en enkelt infusionsdosis på 5 mg/kg ved uge 0.
A total of 306 patients received 3 doses of infliximab 5 mg/kg at week 0, 2 and 6.
I alt 573 patienter med moderat til svært aktiv Crohns sygdom (CDAI ≥ 220 ≤ 400) fik en enkelt infusionsdosis på 5 mg/kg ved uge 0.
A total of 573 patients with moderately to severely active Crohn’s disease (CDAI ≥220 ≤400) received a single infusion of 5 mg/kg at week 0.
I alt 582 patienter blev randomiseret til at få enten nivolumab 3 mg/kg intravenøst over 60 minutter hver 2. uge (n = 292) eller docetaxel 75 mg/m2 hver 3. uge (n = 290).
A total of 582 patients were randomised to receive either nivolumab 3 mg/kg administered intravenously over 60 minutes every 2 weeks (n = 292) or docetaxel 75 mg/m2 every 3 weeks (n = 290).
I alt 59 ud af 85 (69,4%) patienter fra placebo-gruppen fik ublindet sunitinib- behandling efter sygdomsprogression eller afblinding ved studieafslutning.
A total of 59 out of 85 (69.4%) patients from the placebo arm crossed over to open-label sunitinib following disease progression or unblinding at study closure.
I alt 595 patienter med HER2-positiv operabel eller lokalt avanceret brystkræft, inklusive inflammatorisk brystkræft, modtog 8 serier af enten intravenøst formuleret Herceptin eller Herceptin subkutan formulering samtidigt med kemoterapi (4 serier docetaxel, 75 mg/m2 intravenøs infusion, efterfulgt af 4 serier af FEC ([5-fluorouracil, 500 mg/m2; epirubicin, 75 mg/m2; cyclophosphamid, 500 mg/m2 hver enkelt som intravenøs bolus eller infusion]), efterfulgt af operation og fortsat behandling i yderligere 10 serier til i alt et års behandling med enten intravenøst formuleret Herceptin eller Herceptin subkutan formulering efter den originale randomisering.
A total of 595 patients with HER2-positive, operable or locally advanced breast cancer (LABC) including inflammatory breast cancer received eight cycles of either Herceptin intravenous formulation or Herceptin subcutaneous formulation concurrently with chemotherapy (4 cycles of docetaxel, 75 mg/m2 intravenous infusion, followed by 4 cycles of FEC ([5-Fluorouracil, 500 mg/m2; epirubicin, 75 mg/m2; cyclophosphamide, 500 mg/m2 each intravenous bolus or infusion]), followed by surgery, and continued therapy with Herceptin intravenous formulation or Herceptin subcutaneous formulation as originally randomized for 10 additional cycles for a total of one year of treatment.
I alt 595 patienter med HER2-positiv operabel eller lokalt avanceret brystkræft, inklusive inflammatorisk brystkræft, modtog 8 serier af enten intravenøst formuleret Herceptin eller Herceptin subkutan formulering samtidigt med kemoterapi (4 serier docetaxel, 75 mg/m2 intravenøs infusion, efterfulgt af 4 serier af FEC ([5-fluorouracil, 500 mg/m2; epirubicin, 75 mg/m2; cyclophosphamid, 500 mg/m2 hver enkelt som intravenøs bolus eller infusion]), efterfulgt af operation og fortsat behandling i yderligere 10 serier til i alt et års behandling med enten intravenøst formuleret Herceptin eller Herceptin subkutan formulering efter den originale randomisering.
A total of 595 patients with HER2-positive, operable or locally advanced breast cancer (LABC) including inflammatory breast cancer received eight cycles of either Herceptin intravenous formulation or Herceptin subcutaneous formulation concurrently with chemotherapy (4 cycles of docetaxel, 75 mg/m2 intravenous infusion, followed by 4 cycles of FEC ([5-Fluorouracil, 500 mg/m2; epirubicin, 75 mg/m2; cyclophosphamide, 500 mg/m2 each intravenous bolus or infusion]), followed by surgery, and continued therapy with Herceptin intravenous formulation or Herceptin subcutaneous formulation as originally randomized for 10 additional cycles, for a total of one year of treatment.
I alt 6.804 patienter er blevet behandlet med Cosentyx i blindede og åbne kliniske studier inden for forskellige indikationer (plaque psoriasis, psoriasisartrit, ankyloserende spondylitis og andre autoimmunsygdomme).
A total of 6,804 patients have been treated with Cosentyx in blinded and open-label clinical studies in various indications (plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and other autoimmune conditions).
I alt 618 patienter blev randomiseret til at modtage 7 mg (n=205) eller 14 mg (n=216) teriflunomid eller placebo (n=197).
A total of 618 patients were randomized to receive 7 mg (n=205) or 14 mg (n=216) of teriflunomide or placebo (n=197).
I alt 652 patienter (Jetrea 464, placebo 188) blev randomiseret i disse 2 studier (TG-MV-006 og TG-MV-007).
A total of 652 patients (JETREA 464, placebo 188) were randomised in these 2 studies (TG-MV-006 and TG-MV-007).
I alt 676 patienter blev randomiseret: 137 til ipilimumab monoterapigruppen, 403 til ipilimumab + gp100–gruppen og 136 til gp100–gruppen alene.
A total of 676 patients were randomized: 137 to the ipilimumab monotherapy group, 403 to the ipilimumab + gp100 group, and 136 to the gp100 alone group.
I alt 69 patienter fik en total kumulativ dosis på 2,04 g.
Overall, 69 patients received a total cumulative dose of 2.04 g.
I alt 697 patienter randomiseredes i forholdet 2:1 til enten irbesartan/hydrochlorothiazid 150 mg/12,5 mg eller irbesartan 150 mg med systematisk titrering (inden evaluering af responset på den lavere dosis) efter 1 uge til henholdsvis irbesartan/hydrochlorothiazid 300 mg/25 mg eller irbesartan 300 mg.
A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/hydrochlorothiazide 150 mg/12.5 mg or to irbesartan 150 mg and systematically force titrated (before assessing the response to the lower dose) after one week to irbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively.
I alt 7 patienter (0,5% af den behandlede population) døde af infektion, der indtraf under neutropeni.
Overall 8 patients (0.6% of the treated population) died from infection as a complication occurring during neutropenia.
I alt 70,4 % af de pædiatriske patienter, som fik zonisamid i det kontrollerede studie eller dets åbne forlængelse, havde mindst én hydrogencarbonatmåling under 22 mmol/l udløst af behandlingen.
A total of 70.4% of paediatric subjects who received ZNS in the controlled study or its open label extension had at least one treatment-emergent bicarbonate measurement below
I alt 73 patienter modtog det terapeutiske Zevalin regimen, og 70 patienter modtog rituximab, indgivet som en intravenøs infusion på 375 mg/m2 ugentlig gange 4 doser.
A total of 73 patients received the Zevalin therapeutic regimen, and 70 patients received rituximab given as an intravenous infusion at 375 mg/m2 weekly times 4 doses.
I alt 76,5 % (218/285) af de patienter, som fik genbehandling, havde et PGA-respons på “ clear” eller “minimal” efter 16 ugers genbehandling, uanset om de fik tilbagefald i den behandlingsfri periode (69,1 % [123/178] for patienter, som fik tilbagefald, og 88,8 % [95/107] for patienter, som ikke fik tilbagefald).
A total of 76.5% (218/285) of patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1%[123/178] and 88.8% [95/107] for patients who relapsed and who did not relapse during the withdrawal period, respectively).
I alt 760 patienter blev randomiseret 2:1 til at modtage 160 mg regorafenib (4 tabletter Stivarga, der hver indeholder 40 mg regorafenib) oralt én gang dagligt (N=505) plus bedste understøttende behandling (BSC) eller tilsvarende placebo (N=255) plus BSC i 3 uger efterfulgt af 1 uge uden behandling.
In total, 760 patients were randomised 2:1 to receive 160 mg regorafenib (4 tablets Stivarga each containing 40 mg regorafenib) orally once daily (N=505) plus Best Supportive Care (BSC) or matching placebo (N=255) plus BSC for 3 weeks on therapy followed by 1 week off therapy.
I alt 821 patienter blev randomiseret til at få enten nivolumab 3 mg/kg (n=410) som intravenøs administration over 60 minutter hver 2. uge eller everolimus (n=411) 10 mg dagligt oralt.
A total of 821 patients were randomised to receive either nivolumab 3 mg/kg (n=410) administered intravenously over 60 minutes every 2 weeks or everolimus (n=411) 10 mg daily, administered orally.