natgillin/translations-raw huggingface dataset:
I det pivotale kliniske studie, BO21004/CLL11, blev 91% (40 ud af 44) af de evaluérbare patienter behandlet med Gazyvaro B-celle-depleterede (defineret som CD19+ B-celletal <0,07x 109/l) i slutningen af behandlingsperioden og forblev depleterede igennem de første 6 måneder af opfølgningsperioden.
In the pivotal clinical study BO21004/CLL11, 91% (40 out of 44) of evaluable patients treated with Gazyvaro were B-cell depleted (defined as CD19+ B cell counts < 0.07 x 109/L) at the end of treatment period and remained depleted during the first 6 months of follow up.
I det pivotale mCRC-studie forekom anæmi, kvalme, opkastning, obstipation, alopeci, forhøjet basisk fosfatase og hyperbilirubinæmi hos ≥20 % af patienterne.
In the pivotal MCRC study, anaemia, nausea, vomiting, constipation, alopecia, increased alkaline phosphatase, and hyperbilirubinaemia occurred in ≥20% of patients.
I det pivotale mCRC-studie var positive resultater i analysen af neutraliserende antistoffer også hyppigere hos patienterne i placeboarmen [2/526 (0,38 %)] end i ZALTRAP-armen [1/521 (0,19 %)].
Positive results in the neutralising antibody assay in the MCRC pivotal study were also higher in patients treated with the placebo/FOLFIRI regimen [2/526 (0.38%)] than with the ZALTRAP/FOLFIRI regimen [1/521 (0.19%)].
I det pivotale studie (BO16216) blev Herceptin og anastrozol administreret fra dag 1.
In the pivotal trial (BO16216) Herceptin and anastrozole were administered from day 1.
I det pivotale studie BO22227 rapporterede mere end dobbelt så mange patienter behandlet med Herceptin subkutan formulering alle graders hypertension (4,7 % versus 9,8 % i henholdsvis intravenøs og subkutan formulering), hvoraf en større andel af patienterne havde svære bivirkninger (NCI CTCAE ≥ 3), < 1 % versus 2,0 % ved henholdsvis intravenøs og subkutan formulering.
In the pivotal trial BO22227, there were more than twice as many patients reporting all grade hypertension with the Herceptin subcutaneous formulation (4.7 % versus 9.8 % in the intravenous and subcutaneous formulations respectively), with a greater proportion of patients with severe events (NCI CTCAE grade ≥3) <1 % versus 2.0 % the intravenous and subcutaneous formulations respectively.
I det pivotale studie CLEOPATRA blev bivirkninger rapporteret mindre hyppigt efter seponering af doxetaxel.
In the pivotal trial CLEOPATRA, ADRs were reported less frequently after discontinuation of docetaxel treatment.
I det pivotale studie CLEOPATRA med metastatisk brystkræft defineredes en infusionsreaktion som enhver bivirkning, der forekom under infusionen eller på infusionsdagen, og som blev rapporteret som overfølsomhed, anafylaktisk reaktion, akut infusionsreaktion eller cytokinfrigivelsessyndrom.
An infusion reaction was defined in the pivotal trial CLEOPATRA in metastatic breast cancer as any event reported as hypersensitivity, anaphylactic reaction, acute infusion reaction or cytokine release syndrome occurring during an infusion or on the same day as the infusion.
I det pivotale studie CLEOPATRA med metastatisk brystkræft forekom diarré hos 68,4 % i Perjeta- gruppen og hos 48,7 % i placebo-gruppen.
In the pivotal trial CLEOPATRA in metastatic breast cancer, diarrhoea occurred in 68.4% of Perjeta- treated patients and 48.7% of placebo-treated patients.
I det pivotale studie CLEOPATRA med metastatisk brystkræft forekom udslæt hos 51,7 % i Perjeta- gruppen sammenlignet med 38,9 % i placebo-gruppen.
In the pivotal trial CLEOPATRA in metastatic breast cancer, rash occurred in 51.7% of Perjeta-treated patients, compared with 38.9% of placebo-treated patients.
I det pivotale studie CLEOPATRA med metastatisk brystkræft var den samlede hyppighed af overfølsomhed/anafylaksi rapporteret af investigator under hele behandlingsperioden 9,3 % i placebo- gruppen og 11,3 % i Perjeta-gruppen, hvoraf henholdsvis 2,5 % og 2 % var af NCI-CTCAE-grad 3-4.
In the pivotal trial CLEOPATRA in metastatic breast cancer, the overall frequency of investigator reported hypersensitivity/anaphylaxis events during the entire treatment period was 9.3% in the placebo-treated group and 11.3% in the Perjeta-treated group, of which 2.5% and 2.0% were NCI- CTCAE Grade 3-4, respectively.
I det pivotale studie CLEOPATRA med metastatisk brystkræft var hyppigheden af NCI-CTCAE version 3 grad 3-4 neutropeni ensartet i de to behandlingsgrupper (86,3 % i Perjeta-gruppen og 86,6 % i placebo-gruppen, inklusive henholdsvis 60,7 % og 64,8 % grad 4 neutropeni).
In the pivotal trial CLEOPATRA in metastatic breast cancer, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was balanced in the two treatment groups (86.3% of Perjeta-treated patients and 86.6% of placebo-treated patients, including 60.7% and 64.8% Grade 4 neutropenia, respectively).
I det pivotale studie CLEOPATRA med metastatisk brystkræft var incidensen af LVD under studiebehandling højere i placebo-gruppen end i Perjeta-gruppen (henholdsvis 8,6 % og 6,6 %).
In the pivotal trial CLEOPATRA in metastatic breast cancer, the incidence of LVD during study treatment was higher in the placebo-treated group than in the Perjeta-treated group (8.6% and 6.6%, respectively).
I det pivotale studie CLEOPATRA oplevede størstedelen af patienterne i begge behandlingsgrupper mindst et tilfælde af leukopeni (63,0 % i Perjeta-gruppen og 58,3 % i placebo-gruppen), som i de fleste tilfælde var neutropeni.
In the pivotal trial CLEOPATRA, the majority of patients in both treatment groups experienced at least one leucopenic event (63.0% of patients in the Perjeta-treated group and 58.3% of patients in the placebo-treated group), of which the majority were neutropenic events.
I det pivotale studie fik 166 patienter med recidiverende eller kemoterapi-resistent lavmalignt eller follikulært B-celle NHL 375 mg/m2 MabThera som intravenøs infusion én gang om ugen i fire uger.
In the pivotal trial, 166 patients with relapsed or chemoresistant low-grade or follicular B cell NHL received 375 mg/m2 of MabThera as an intravenous infusion once weekly for four weeks.
I det pivotale studie for ubehandlet CLL (OMB110911), blev der set forlænget neutropeni (defineret som neutropeni af grad 3 eller 4, som ikke blev korrigeret indenfor 24 og 48 dage efter sidste behandling) hos 41 patienter (23 patienter, der blev behandlet med ofatumumab og chlorambucil, 18 patienter, der blev behandlet med chlorambucil alene).
In the pivotal study for untreated CLL (OMB110911), prolonged neutropenia (defined as Grade 3 or 4 neutropenia not resolved between 24 and 42 days of last treatment) was reported in 41 patients (23 patients treated with ofatumumab and chlorambucil, 18 patients treated with chlorambucil alone).
I det pivotale studie GAO4735g oplevede 1 % af patienterne gastrointestinal perforation.
In the pivotal study GAO4753g 1% of patients experienced gastrointestinal perforation.
I det pivotale studie med indolent non-Hodgkin lymfom var 44% (85 ud af 194) af patienterne, der blev behandlet med Gazyvaro plus bendamustin 65 år eller derover.
In the pivotal study in iNHL, 44% (85 out of 194) of patients treated with Gazyvaro plus bendamustine were 65 years or older.
I det pivotale studie med indolent non-Hodgkin lymfom, GAO4753g, havde 2 patienter i Gazyvaro plus bendamustin-armen en positiv Human Anti-Human Antibody (HAHA) vurdering ved baseline og oplevede infusionsrelaterede reaktioner.
In the iNHL pivotal trial, GAO4753g, two patients in the G+B arm had a positive HAHA (Human Anti-Human Antibody) assessment at baseline and experienced IRRs.
I det pivotale studie med indolent non-Hodgkin lymfom, havde en lille subgruppe på 8% af patienterne (15 ud af 194), der blev behandlet med Gazyvaro plus bendamustin, moderat nedsat nyrefunktion (CrCl <50 ml/min).
In the pivotal study in iNHL, a small subset of 8% (15 out of 194) of patients treated with Gazyvaro plus bendamustine, had moderate renal impairment (CrCL < 50 mL/min).
I det pivotale studie med mCRC-patienter blev ATE (inklusive transitorisk iskæmisk attak, cerebrovaskulær hændelse, angina pectoris, intrakardiel trombe, myokardieinfarkt, arteriel emboli og iskæmisk colitis) indberettet hos 2,6 % af patienterne i ZALTRAP-armen og hos 1,5 % i placeboarmen.
In the pivotal study of MCRC patients, ATE (including transient ischaemic attack, cerebrovascular accident, angina pectoris, intracardiac thrombus, myocardial infarction, arterial embolism, and ischaemic colitis) were reported in 2.6% of patients treated with the ZALTRAP/FOLFIRI regimen and 1.5% of patients treated with the placebo/FOLFIRI regimen.
I det pivotale studie med mCRC-patienter blev der indberettet fistler (anale, enterovesikale, enterokutane, kolovaginale, intestinale) hos 9 ud af 611 patienter (1,5 %) i ZALTRAP-armen og hos 3 ud af 605 patienter (0,5 %) i placeboarmen.
In the pivotal study of MCRC patients, fistulas (anal, enterovesical, enterocutaneous, colovaginal, intestinal sites) were reported in 9 of 611 patients (1.5%) treated with the ZALTRAP/FOLFIRI regimen and 3 of 605 patients (0.5%) treated with the placebo/FOLFIRI regimen.
I det pivotale studie med mCRC-patienter blev der indberettet GI-perforation (alle grader) hos 3 ud af 611 patienter i ZALTRAP-armen og hos 3 ud af 605 patienter i placeboarmen.
In the pivotal study of MCRC patients, GI perforation (all grades) was reported in 3 of 611 patients (0.5%) treated with the ZALTRAP/FOLFIRI regimen and 3 of 605 patients (0.5%) treated with the placebo/FOLFIRI regimen.
I det pivotale studie med mCRC-patienter blev der indberettet neutropeni (alle grader) hos 67,8 % af patienterne i ZALTRAP-armen og hos 56,3 % i placeboarmen.
In the pivotal study of MCRC patients, neutropenia (all grades) has been reported in 67.8% of patients treated with ZALTRAP/FOLFIRI and 56.3% of patients treated with placebo/FOLFIRI.
I det pivotale studie med mCRC-patienter blev der indberettet proteinuri (sammensat af kliniske data og laboratoriedata) hos 62,2 % af patienterne i ZALTRAP-armen og hos 40,7 % i placeboarmen.
In the pivotal study of MCRC patients, proteinuria (compiled from clinical and laboratory data) was reported in 62.2% patients treated with the ZALTRAP/FOLFIRI regimen compared to 40.7% patients treated with the placebo/FOLFIRI regimen.
I det pivotale studie med mCRC-patienter blev der rapporteret alle grader af VTE hos 9,3 % af patienterne i ZALTRAP-armen og hos 7,3 % i placeboarmen.
In the pivotal study of MCRC patients, all grades VTE occurred in 9.3% of patients treated with the ZALTRAP/FOLFIRI regimen and 7.3% of patients treated with the placebo/FOLFIRI regimen.
I det pivotale studie med mCRC-patienter blev kompromitteret sårheling indberettet hos 3 af patienterne (0,5 %) i ZALTRAP-armen og hos 5 af patienterne (0,8 %) i placeboarmen.
In the pivotal study for MCRC, compromised wound healing was reported in 3 patients (0.5%) treated with the ZALTRAP/FOLFIRI regimen and 5 patients (0.8%) treated with the placebo/FOLFIRI regimen.
I det pivotale studie med mCRC-patienter er der observeret diarré (alle grader) hos 69,2 % af patienterne i ZALTRAP-armen og hos 56,5 % i placeboarmen.
In the pivotal study of MCRC patients, diarrhoea (all grades) has been observed in 69.2% of patients treated with ZALTRAP/FOLFIRI and 56.5% of patients treated with placebo/FOLFIRI.
I det pivotale studie med mCRC-patienter er der rapporteret om hypertension (alle grader) hos 41,2 % af patienterne i ZALTRAP-armen og hos 10,7 % i placeboarmen.
In the pivotal study of MCRC patients, hypertension (all grades) has been reported in 41.2% of patients treated with ZALTRAP/FOLFIRI and 10.7% of patients treated with placebo/FOLFIRI.
I det pivotale studie med ubehandlede CLL-patienter (OMB110911) blev der set forlænget neutropeni (defineret som neutropeni af grad 3 eller 4, som ikke blev korrigeret indenfor 24 og 48 dage efter sidste behandling) hos 41 patienter (23 patienter, der blev behandlet med ofatumumab og chlorambucil, 18 patienter, der blev behandlet med chlorambucil alene).
In the pivotal study for untreated CLL (OMB110911), prolonged neutropenia (defined as Grade 3 or 4 neutropenia not resolved between 24 and 42 days of last treatment) was reported in 41 patients (23 patients treated with ofatumumab and chlorambucil, 18 patients treated with chlorambucil alone).
I det pivotale studie var 46% (156 ud af 336) af patienterne med kronisk lymfatisk leukæmi, der blev behandlet med Gazyvaro plus chlorambucil 75 år eller derover (medianalder var 74 år).
In the pivotal study, 46% (156 out of 336) of patients with CLL treated with Gazyvaro plus chlorambucil were 75 years or older (median age was 74 years).
I det pivotale studie var hyppigheden af administrationsrelaterede reaktioner 37,2 % ved intravenøst formuleret Herceptin og 47,8 % ved Herceptin subkutan formulering.
In the pivotal trial, the rate of all grade ARRs was 37.2 % with the Herceptin intravenous formulation and 47.8 % with the Herceptin subcutaneous formulation; severe grade 3 reactions were reported in
I det pivotale to-års studie hos postmenopausale kvinder med osteoporose (BM 16550) var sikkerheden af i.v. behandling med Bondenza 3 mg hver 3 måned og oral ibandronsyre 2,5 mg daglig den samme.
In the pivotal two-year study in postmenopausal women with osteoporosis (BM16550), the overall safety of intravenous injection of Bondenza 3 mg every 3 months and oral ibandronic acid 2.5 mg daily were shown to be similar.
I det pivotale to-års studie hos postmenopausale kvinder med osteoporose (BM 16550) var sikkerheden af i.v. behandling med Bonviva 3 mg hver 3 måned og oral ibandronsyre 2,5 mg daglig den samme.
In the pivotal two-year study in postmenopausal women with osteoporosis (BM16550), the overall safety of intravenous injection of Bonviva 3 mg every 3 months and oral ibandronic acid 2.5 mg daily were shown to be similar.
I det pivotale to-års studie hos postmenopausale kvinder med osteoporose (BM 16550) var sikkerheden af i.v. behandling med ibandronsyre 3mg hver 3 måned og oral ibandronsyre 2,5 mg daglig den samme.
In the pivotal two-year study in postmenopausal women with osteoporosis (BM16550), the overall safety of intravenous injection of ibandronic acid 3 mg every 3 months and oral ibandronic acid 2.5 mg daily were shown to be similar.
I det pivotale, randomiserede, observatørblindede studie V59P20, hvor personerne blev stratificeret i henhold til alder (2-5 år og 6-10 år), blev immunogeniciteten af en enkelt dosis Menveo, målt én måned efter vaccination, sammenlignet med en enkelt dosis ACWY-D.
In the pivotal, randomised, observer-blind study V59P20, in which participants were stratified by age (2 through 5 years and 6 through 10 years), the immunogenicity of a single dose of Menveo one month post vaccination was compared with the single dose of ACWY-D.
I det placebokontrollerede 2-års studie blev hypertension rapporteret som en bivirkning hos 6,5 % af patienterne i behandling med fingolimod 0,5 mg og hos 3,3 % af placebopatienterne.
In the two-year placebo-controlled study, hypertension was reported as an adverse event in 6.5% of patients on fingolimod 0.5 mg and in 3.3% of patients on placebo.
I det placebokontrollerede fase 3-studie med patienter med PAH blev der set en forbigående stigning i den gennemsnitlige hjertefrekvens på 3-4 bpm 2-4 timer efter indgivelse af dosis.
In the Phase 3 placebo-controlled study in patients with PAH, a transient increase in mean heart rate of 3–4 bpm at 2–4 hours post-dose was observed.
I det placebokontrollerede fase III-GIST-studie var den samlede forekomst af hypertension 59,1 % hos patienter i behandling med Stivarga, sammenlignet med 27,3 % hos patienter, der fik placebo.
In the placebo-controlled GIST phase III trial, the overall incidence of hypertension was 59.1% in patients treated with Stivarga as compared to 27.3% in patients receiving placebo.
I det placebokontrollerede fase III-GIST-studie var den samlede forekomst af hånd-fod-hudreaktion 66,7 % i Stivarga-armen sammenlignet med 15,2 % i placebo-armen.
In the placebo-controlled GIST phase III trial, the overall incidence of hand-foot skin reaction was 66.7% in patients treated with Stivarga as compared to 15.2% in patients receiving placebo.
I det placebokontrollerede fase III-studie hos patienter med metastaserende KRC var den samlede forekomst af proteinuri, som opstod under behandlingen, 7,4 % hos patienter i behandling med Stivarga, sammenlignet med 2,4 % hos patienter, der fik placebo.
In the placebo-controlled phase III trial in patients with metastatic CRC, the overall incidence of treatment emergent proteinuria was 7.4% in patients treated with Stivarga as compared to 2.4% in patients receiving placebo.
I det placebokontrollerede fase III-studie med metastaserende KRC var den samlede forekomst af hånd-fod-hudreaktion 45,2 % hos patienter behandlet med Stivarga, sammenlignet med 7,1 % hos patienter, der fik placebo.
In the placebo-controlled metastatic CRC phase III trial, the overall incidence of hand-foot skin reaction was 45.2% in patients treated with Stivarga as compared to 7.1% in patients receiving placebo.
I det placebokontrollerede fase III-studie på metastaserende KRC var den samlede forekomst af hypertension 30,4 % hos patienter behandlet med Stivarga, sammenlignet med 7,9 % hos patienter, der fik placebo.
In the placebo-controlled metastatic CRC phase III trial the overall incidence of hypertension was 30.4% in patients treated with Stivarga as compared to 7.9% in patients receiving placebo.
I det prospektive, randomiserede, kontrollerede, studie med kardiovaskulære endepunkter var investigatorindberettede tilfælde af hypoglykæmi på samme niveau hos patienter, der fik placebo (6,5 %), og patienter, der fik alogliptin (6,7 %) i tillæg til standardbehandling.
In the prospective randomized controlled cardiovascular outcomes study, investigator reported events of hypoglycemia were similar in patients receiving placebo (6.5%) and patients receiving alogliptin (6.7%) in addition to standard of care.
I det prospektive, randomiserede, kontrollerede, studie med kardiovaskulære endepunkter var investigatorindberettede tilfælde af hypoglykæmi på samme niveau hos patienter, der fik placebo (6,5 %), og patienter, der fik alogliptin (6,7 %), i tillæg til standardbehandling.
In the prospective randomized controlled cardiovascular outcomes study, investigator reported events of hypoglycemia were similar in patients receiving placebo (6.5%) and patients receiving alogliptin (6.7%) in addition to standard of care.
I det prospektive, randomiserede, kontrollerede, studie med kardiovaskulære endepunkter var investigatorindberettede tilfælde af hypoglykæmi på samme niveau hos patienter, der fik placebo (6,5 %), og patienter, der fik alogliptin (6.7 %) i tillæg til standardbehandling.
In the prospective randomized controlled cardiovascular outcomes study, investigator reported events of hypoglycemia were similar in patients receiving placebo (6.5%) and patients receiving alogliptin (6.7%) in addition to standard of care.
I det prospektive, randomiserede, kontrollerede, studiet med kardiovaskulære endepunkter var investigatorindberettede tilfælde af hypoglykæmi på samme niveau hos patienter, der fik placebo (6,5 %), og patienter, der fik alogliptin (6,7 %) i tillæg til standardbehandling.
In the prospective randomized controlled cardiovascular outcomes study, investigator reported events of hypoglycemia were similar in patients receiving placebo (6.5%) and patients receiving alogliptin (6.7%) in addition to standard of care.
I det præ- og postnatale studie sås en stigning i fostermortalitet ved doser, der var toksiske for moderdyret (en dosis, der svarer til en plasmaeksponering 4 gange højere end observeret hos patienter).
In the pre- and post-natal study, an increase in foetal mortality was observed at doses that were toxic to the dams (a dose corresponding to a plasma exposure level 4-fold higher than observed in patients).
I det præ- og postnatale studier sås en stigning i fostermortalitet ved doser, der var toksiske for moderdyret (en dosis, der svarer til en plasmaeksponering 4 gange højere end observeret hos patienter).
In the pre- and post-natal study, an increase in foetal mortality was observed at doses that were toxic to the dams (a dose corresponding to a plasma exposure level 4-fold higher than observed in patients).
I det præ- og postnatale udviklingsstudie hos rotter sås ingen uønskede påvirkninger af graviditeten, fødslen eller diegivningen hos F0-hunrotter ved en maternel, ikke- toksiske doser (10 og 20 mg/kg/dag).
In the pre- and post-natal development study in rats, there were no undesirable effects on pregnancy, parturition or lactation of F0 female rats at maternally non-toxic doses (10 and
I det prædefinerede stratum, som blev anvendt til at sammenligne fondaparinux med placebo (dvs. patienter, der blev behandlet med ikke-fibrinselektivt fibrinolytika (77,3), ingen reperfusion (22 %), fibrinselektive fibrinolytika (0,3 %), primær PCI (0,4 %)), var incidensen af død/re-MI efter 30 dage signifikant reduceret fra 14,0 % for placebo til 11,3 % (hazard ratio 0,80; 95 % CI, 0,69-0,93; p = 0,003).
In the predefined stratum comparing fondaparinux to placebo (i.e patients treated with non- fibrin specific lytics (77.3%), no reperfusion (22%), fibrin-specific lytics (0.3%), primary PCI (0.4%), the incidence of death/re-MI at Day 30 was significantly reduced from 14.0% on placebo to 11.3% (hazard ratio 0.80, 95% CI, 0.69, 0.93, p = 0.003).
I det randomiserede fase 3-studie 1014 sås ALAT- eller ASAT- stigning til grad 3 eller 4 hos 15% og 8% af de patienter, der fik crizotinib, mod 2% og 1% af de patienter, der fik kemoterapi.
In randomised Phase 3 Study 1014, increases to Grade 3 or 4 ALT or AST elevations were observed in 15% and 8% of patients receiving crizotinib versus 2% and 1% of patients receiving chemotherapy.
I det randomiserede studie CC-4047-MM-003 blev 302 patienter med relaps og refraktær myelomatose eksponeret for 4 mg pomalidomid administreret én gang dagligt i 21 dage i hver cyklus på 28 dage, i kombination med en ugentlig lav dosis dexamethason.
In randomised study CC-4047-MM-003, 302 patients with relapsed and refractory multiple myeloma were exposed to 4 mg pomalidomide administered once daily for 21 days of each 28 day cycle in combination with a weekly low dose of dexamethasone.
I det randomiserede studie forekom neutropeni af grad 3-4 oftere hos personer behandlet med Pixuvri, men var i de fleste tilfælde ukompliceret, ikke-kumulativ og forbundet med en lav forekomst af febril neutropeni eller infektioner.
While grade 3-4 neutropenia occurred in the randomised trial more frequently among Pixuvri recipients, it was uncomplicated in the majority of cases, noncumulative and associated with a low incidence of febrile neutropenia or infections.
I det randomiserede, aktiv-kontrollerede forsøg var PFS efter 6 måneder 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).
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
I det randomiserede, dobbeltblindede, aktivt kontrollerede, kliniske multicenterstudie blev den anbefalede dosis på 400 mg to gange dagligt anvendt hos behandlingsnaive patienter i kombination med en fastsat dosis emtricitabin på 200 mg (+) tenofovir 245 mg hos 281 patienter; til sammenligning fik 282 patienter efavirenz 600 mg (ved sengetid) i kombination med emtricitabin (+) tenofovir.
In treatment-naïve patients, the multi-centre, randomised, double-blind, active-controlled clinical study used the recommended dose of 400 mg twice daily in combination with a fixed dose of emtricitabine 200 mg (+) tenofovir 245 mg in 281 patients, in comparison to 282 patients taking efavirenz (EFV) 600 mg (at bedtime) in combination with emtricitabine (+) tenofovir.