natgillin/translations-raw huggingface dataset:
I det første tre-års randomiserede, dobbeltblindede, placebokontrollerede frakturstudie (MF 4411) påvistes et statistisk signifikant og medicinsk relevant fald i hyppigheden af nye røntgen- morfometriske og kliniske vertebrale frakturer (tabel 3).
In the initial three-year, randomised, double-blind, placebo-controlled, fracture study (MF 4411), a statistically significant and medically relevant decrease in the incidence of new radiographic morphometric and clinical vertebral fractures was demonstrated (table 3).
I det første tre-års, randomiserede, dobbeltblindede, placebokontrollerede frakturstudie (MF 4411) påvistes et statistisk signifikant og medicinsk relevant fald i hyppigheden af nye røntgen- morfometriske og kliniske vertebrale frakturer (tabel 3).
In the initial three-year, randomised, double-blind, placebo-controlled, fracture study (MF 4411), a statistically significant and medically relevant decrease in the incidence of new radiographic morphometric and clinical vertebral fractures was demonstrated (table 3).
I det første treårs randomiserede, dobbeltblinde, placebokontrollerede frakturstudie (MF 4411) påvistes et statistisk signifikant og medicinsk relevant fald i hyppigheden af nye røntgen- morfometriske og kliniske vertebrale frakturer (tabel 3).
In the initial three-year, randomised, double-blind, placebo-controlled, fracture study (MF 4411), a statistically significant and medically relevant decrease in the incidence of new radiographic morphometric and clinical vertebral fractures was demonstrated (table 3).
I det første trin af behandlingen udtages der fra patienten på hospitalet et lille stykke sundt limbalt væv (12 mm2), som samme dag sendes til fremstilleren.
In the first stage of treatment, a small part of healthy limbal tissue (12 mm2 in size) is taken from the patient in hospital and sent to the manufacturer on the same day.
I det første år fik de patienter, der blev behandlet med Plegridy hver anden eller fjerde uge, i gennemsnit færre tilbagefald end de, der fik placebo, nemlig henholdsvis 0,26 og 0,29 tilbagefald mod 0,40.
During the first year, patients treated with Plegridy every two or four weeks experienced fewer relapses on average than patients on placebo: 0.26 and 0.29 relapses versus 0.40, respectively.
I det første år fik patienterne hver anden eller hver fjerde uge Plegridy eller virkningsløs behandling (placebo), og i det andet år fik alle patienterne Plegridy hver anden eller hver fjerde uge.
During the first year, patients were given Plegridy every two or four weeks, or placebo (a dummy treatment); during the second year, all patients were given Plegridy every two or four weeks.
I det første, placebokontrollerede kliniske forsøg var Fabrazyme effektivt til clearance af GL-3 fra det vaskulære endotel i nyrerne efter 20 ugers behandling.
In the first placebo-controlled clinical trial, Fabrazyme was effective in clearing GL-3 from the vascular endothelium of the kidney after 20 weeks of treatment.
I det internationale, dobbeltblindede multicenterstudie SAILING (ING111762) blev 719 hiv-1-inficerede voksne, der tidligere havde fået antiretroviral behandling (ART), randomiseret og fik enten 50 mg dolutegravir én gang daglig eller 400 mg raltegravir 2 gange daglig med et af investigator udvalgt baggrundsregime, som bestod af op til 2 stoffer (med mindst ét fuldt aktivt stof).
In the international multicentre, double-blind SAILING study (ING111762), 719 HIV-1 infected, antiretroviral therapy (ART)-experienced adults were randomized and received either dolutegravir 50 mg once daily or raltegravir 400 mg twice daily with investigator selected background regimen consisting of up to 2 agents (including at least one fully active agent).
I det investigator-sponsorerede CHIPS-studie (Chronic Hepatitis C International Paediatric Study) blev 65 børn og unge (6-18 år) med kronisk HCV-infektion behandlet med Pegasys 100 mikrogram/m2 subkutant én gang om ugen og ribavirin 15 mg/kg/dag.
In the investigator sponsored CHIPS study (Chronic Hepatitis C International Paediatric Study), 65 children and adolescents (6-18 years) with chronic HCV infection were treated with Pegasys
I det kardio-vaskulære system, forebygger spironolakton aldosterons nedbrydende effekter.
In the cardiovascular system, spironolactone prevents the detrimental effects of aldosterone.
I det klinisk forsøg IMP24011 opnåede ca. halvdelen (46,8%) af patienterne, som var delvise respondenter (50% til 74% forbedring ved PASI svarende til PGA ’good’) efter 12 ugers Raptiva behandling et PASI 75 respons ved uge 24.
In study IMP24011, approximately half of the patients (46.8%) who were partial responders (50% to 74% improvement on PASI, similar to PGA good) after 12 weeks of Raptiva treatment achieved a PASI 75 response at week 24.
I det kliniske fase 3 forsøg blev farmakokinetikken af drotrecogin alfa (aktiveret) evalueret hos 342 patienter med svær sepsis, som fik administreret 24 g/kg/time kontinuerligt infunderet over 96 timer.
In the Phase 3 trial, the pharmacokinetics of drotrecogin alfa (activated) were evaluated in 342 patients with severe sepsis administered a 96-hour continuous infusion at 24 g/kg/hr.
I det kliniske fase 3 forsøg blev farmakokinetikken af drotrecogin alfa (aktiveret) evalueret hos 342 patienter med svær sepsis, som fik administreret 24 g/kg/time, kontinuerligt infunderet over 96 timer.
In the Phase 3 trial, the pharmacokinetics of drotrecogin alfa (activated) were evaluated in 342 patients with severe sepsis administered a 96-hour continuous infusion at 24 g/kg/hr.
I det kliniske fase 3-studie C211 var der ingen forskel mellem den type varianter, der opstod hos patienter, som fik telaprevir 1.125 mg to gange dagligt, og typen hos patienter, som fik telaprevir 750 mg hver 8. time.
In the C211 Phase 3 clinical trial, there was no difference in the type of emerging variants between patients receiving telaprevir 1,125 mg twice daily (b.i.d.) and patients receiving telaprevir 750 mg every 8 hours (q8h).
I det kliniske fase I/II-studie med patienter med Ph+ leukæmi, der tidligere var blevet behandlet, blev der set forlænget QTcF-interval > 60 msek. i forhold til baseline hos 6 (1,1 %) ud af 562 patienter.
In the Phase 1/2 clinical study in patients with previously treated Ph+ leukaemias, QTcF interval changes >60 ms from baseline were observed 6 (1.1%) of 562 patients.
I det kliniske fase II- SSA-studie med eltrombopag blev nye cytogenetiske anomalier set hos 19 % af patienterne [8/43 (hvoraf 5 havde ændringer i kromosom 7)].
In the phase II SAA clinical study with eltrombopag, the incidence of new cytogenetic abnormalities was observed in 19% of patients [8/43 (where 5 of them had changes in chromosome 7)].
I det kliniske fase II-studie med voksne patienter med tidligere behandlet Ph+ leukæmi var det tilladt at øge dosis til 600 mg 1 gang dagligt sammen med føde hos patienter, der ikke oplevede svære eller vedvarende moderate bivirkninger, ved en af nedenstående betingelser.
In the Phase 2 clinical trial of adult patients with previously treated Ph+ leukaemia, dose escalation to 600 mg once daily with food was allowed in patients who did not experience severe or persistent moderate-adverse reactions, under any of the following circumstances.
I det kliniske fase III-forsøg (RECOURSE) forekom behandlingsrelaterede infektioner oftere hos Lonsurf-behandlede patienter (5,6%) end hos patienter i placebogruppen (1,9%).
In the Phase III (RECOURSE) clinical trial, treatment-related infections occurred more frequently in Lonsurf-treated patients (5.6%) compared to those receiving placebo (1.9%).
I det kliniske forsøg, der undersøgte effekten af ONIVYDE, var højere plasmaeksponering for total- irinotecan og total-SN-38 hos patienterne i ONIVYDE + 5-FU/LV-gruppen forbundet med længere OS og PFS samt højere ORR.
In the clinical trial demonstrating effectiveness of ONIVYDE, higher plasma exposures of total irinotecan and SN-38 for patients in the ONIVYDE+5-FU/LV treatment arm were associated with longer OS and PFS as well as with higher ORR (objective response rate).
I det kliniske program forekom der ni tilfælde af utilsigtet ekstravasation med Myocet, hvor ingen af tilfældene var forbundet med alvorlig hudbeskadigelse, ulceration eller nekrose.
In the clinical program, there were nine cases of accidental extravasation of Myocet, none of which were associated with severe skin damage, ulceration or necrosis.
I det kliniske studie 301 var de patienter, som havde forhøjet ALAT eller ASAT ved baseline, mere tilbøjelige til at få forhøjede leverfunktionsprøver end dem, som havde normale værdier ved start.
In the 301 clinical study, patients whose baseline ALT or AST were elevated were more likely to experience liver function test elevations than those beginning with normal values.
I det kliniske studie af kvinder mellem 24 og 45 år, blev 98,4 %, 98,1 %, 98,8 % og 97,4 % af de kvinder, der fik Gardasil, henholdsvis anti-HPV 6, anti-HPV 11, anti- HPV 16 og anti-HPV 18 seropositive én måned efter 3. dosis.
In the clinical study in women 24 to 45 years, 98.4%, 98.1%, 98.8%, and 97.4% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3.
I det kliniske studie AS001 rapporterede patienter behandlet med Cimzia signifikante forbedringer i fysisk funktion, hvilket blev vurderet ved BASFI, og i smerter, hvilket blev vurderet ved Total og Nocturel Back Pain NRS skala, sammenlignet med placebo.
In the AS001 clinical trial, Cimzia-treated patients reported significant improvements in physical function as assessed by the BASFI and in pain as assessed by the Total and Nocturnal Back Pain NRS scales as compared to placebo.
I det kliniske studie CIR 217 blev sikkerhed, smitsomhed og immunogenicitet af en levende svækket vaccine afledt af A/Vietnam/1203/2004 (H5N1)-influenzaisolat undersøgt hos 21 forsøgspersoner, som fik en dosis på 106,7 TCID50 (median tissue culture infective dose); 18 af disse forsøgspersoner fik en 2. dosis 4-8 uger senere.
In clinical study CIR 217 the safety, infectivity, and immunogenicity of a live attenuated, vaccine derived from A/Vietnam/1203/2004 (H5N1) influenza isolate were evaluated in 21 subjects who received one 106.7 median tissue culture infectious dose (TCID50) , with 18 of those subjects receiving a second dose 4-8 weeks later.
I det kliniske studie CIR 239 blev sikkerhed, smitsomhed og immunogenicitet af en levende svækket vaccine afledt af A/Hong Kong/213/2003 (H5N1)-influenzaisolat undersøgt hos 17 forsøgspersoner, som fik en dosis på 107,5 TCID50 af vaccinen intranasalt i isolation, og 16 af disse forsøgspersoner fik en 2. dosis 4-8 uger senere.
In clinical study CIR 239 the safety, infectivity, and immunogenicity of a live attenuated vaccine derived from A/Hong Kong/213/2003 (H5N1) influenza isolate were evaluated in 17 subjects who received one dose of 107.5 TCID50 of the vaccine intranasally in isolation, with 16 of those subjects receiving a second dose 4-8 weeks later.
I det kliniske studie D9902B (IMPACT) blev 237 ud af de 512 randomiserede patienter vurderet for udvikling af humorale eller cellulære immunreaktioner (T-celleproliferation og gamma-interferon-(γ-interferon)-ELISPOT) på målantigener ved baseline i uge 6, 14 og 26.
In clinical study D9902B (IMPACT), 237 out of the 512 patients randomized were evaluated for the development of humoral or cellular immune responses (T cell proliferation and gamma-interferon (γIFN) ELISPOT) to the target antigens at baseline, and at Weeks 6, 14, and 26.
I det kliniske studie forekom diarré af grad 3 eller 4 hos 15 ud af 117 patienter (12,8 %), som fik ONIVYDE + 5-FU/LV.
In the clinical study Grade 3 or Grade 4 diarrhoea occurred in 15 out of 117 patients (12.8%) receiving ONIVYDE+5-FU/LV.
I det kliniske studie forekom tidligt indsættende diarré hos 35 patienter (29,9 %), og kolinerge bivirkninger forekom hos 4 patienter (3,4 %), som fik ONIVYDE + 5-FU/LV.
In the clinical study, early diarrhoea onset occurred in 35 patients (29.9%) and cholinergic events occurred in 4 patients (3.4%) receiving ONIVYDE+5-FU/LV.
I det kliniske studie MI-CP217 blev sikkerhed og deskriptiv immunogenicitet af en levende svækket monovalent influenzavaccine (afledt af A/California/7/2009), udviklet til 2009 H1N1-pandemien, vurderet hos i alt 326 randomiserede forsøgspersoner, og 324 forsøgspersoner fik én dosis af det undersøgte lægemiddel (259 forsøgspersoner fik monovalent vaccine; 65 forsøgspersoner fik placebo).
In clinical study MI-CP217 the safety and descriptive immunogenicity of a live attenuated monovalent influenza virus vaccine (derived from A/California/7/2009) developed for the 2009 H1N1 pandemic were evaluated in a total of 326 randomised subjects (259 subjects monovalent vaccine; 65 subjects placebo) and 324 subjects received one dose of investigational product.
I det kliniske studie PsA001 rapporterede patienter behandlet med Cimzia signifikante forbedringer i fysisk funktion, vurderet ved Health Assessment Questionnaire – Disability Index (HAQ-DI), i smerter, vurderet ved PAAP, og i træthed (fatigue), som beskrevet i Fatigue Assessment Scale (FAS), sammenlignet med placebo.
In PsA001 clinical trial, Cimzia-treated patients reported significant improvements in physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI), in pain as assessed by the PAAP and in tiredness (fatigue) as reported by the Fatigue Assessment Scale (FAS) as compared to placebo.
I det kliniske studie var hyppigheden af gastrointestinal perforation sammenlignelig i behandlingsgrupperne.
The frequency of gastrointestinal perforation was comparable between the treatment arms in the clinical study.
I det kliniske studie var middel endelige dosis desoxycorton pivalat 1,9 mg/kg (interval
In the clinical trial, the mean final dose of desoxycortone pivalate was 1.9 mg/kg (range 1.2
I det kliniske studie, der evaluerede ONIVYDE + 5-FU/LV, oplevede 5 ud af 8 undervægtige patienter en bivirkning af grad 3 eller 4, især myelosuppression, mens dosisændring, f.eks. udskydelse af dosis, dosisreduktion eller seponering var nødvendig hos 7 ud af 8 patienter.
In the clinical study evaluating ONIVYDE+5-FU/LV, 5 of 8 underweight patients experienced a Grade 3 or 4 adverse reactions, mostly myelosuppression, while 7 of the 8 patients required dose modification such as dose delay, dose reduction or dose discontinuation.
I det kliniske studieprogram blev naloxegol ikke undersøgt hos patienter med nyligt myokardieinfarkt (inden for 6 måneder), symptomatisk kongestivt hjertesvigt, åbenlys kardiovaskulær (CV) sygdom i anamnesen eller hos patienter med et QT-interval ≥ 500 msek.
Naloxegol was not studied in the clinical trial programme in patients who had a recent history of myocardial infarction within 6 months, symptomatic congestive heart failure, overt cardiovascular (CV) disease or patients with a QT interval of  500 msec.
I det kliniske udviklingsprogram blev den orale vedligeholdelsesbehandling med antiarytmika pauseret i mindst 2 timer efter administration af BRINAVESS.
Within the clinical development program, oral maintenance antiarrhythmic therapy was halted for a minimum of 2 hours after BRINAVESS administration.
I det kliniske udviklingsprogram med raltegravir hos behandlingserfarne patienter forekom udslæt uanset årsagssammenhæng hyppigere, når regimet indeholdt PREZISTA + raltegravir, end når det indeholdt PREZISTA uden raltegravir eller raltegravir uden PREZISTA.
During the clinical development program of raltegravir in treatment-experienced patients, rash, irrespective of causality, was more commonly observed with regimens containing PREZISTA + raltegravir compared to those containing PREZISTA without raltegravir or raltegravir without PREZISTA.
I det kortere (10-ugers) placebo-kontrollerede induktionsstudie, GEMINI III, var de rapporterede typer bivirkninger tilsvarende, men forekom med mindre hyppighed end i de længere 52-ugers forsøg.
In the shorter (10 week) placebo controlled induction trial, GEMINI III, the types of adverse reactions reported were similar but occurred at lower frequency than the longer 52 week trials.
I det kortvarige, placebo-kontrollerede fast-dosis-studie has unge oplevede en højere procentdel af deltagerne i INVEGA-armen (6-19 % afhængigt af dosis) en stigning i kropsvægt på ≥7 % i forhold til deltagere i placebo-armen (2 %).
In the short-term, placebo-controlled, fixed-dose adolescent study, a higher percentage of INVEGA-treated subjects (6-19% depending on dose) had an increase in body weight of ≥7% compared to placebo-treated subjects (2%).
I det kortvarige, placebo-kontrollerede fast-dosis-studie hos unge oplevede en højere procentdel af deltagerne i INVEGA-armen (6-19 % afhængigt af dosis) en stigning i kropsvægt på ≥7 % i forhold til deltagerne i placebo-armen (2 %).
In the short-term, placebo-controlled, fixed-dose adolescent study, a higher percentage of INVEGA-treated subjects (6-19% depending on dose) had an increase in body weight of ≥7% compared to placebo-treated subjects (2%).
I det langvarige studie blev i alt 2072 patienter behandlet med 30 mg tolvaptan med standardbehandling, og 2061 fik placebo med standardbehandling.
In the long-term outcome trial, a total of 2072 patients received 30 mg tolvaptan with standard of care (SC) and 2061 received placebo with SC.
I det midterste tarmstykke hos følsomme insekter, spalter insektets enzymer en carboxymetylgruppe fra modersubstansen til indoxacarb, som derved omdannes til sin bioaktive form.
In the mid-gut of susceptible insect species, the insect’s enzymes remove the carbomethoxy group from parent indoxacarb, and convert it into its biologically active form.
I det midterste tarmstykke, hos følsomme insekter, spalter insektets enzymer en carboxymetylgruppe fra modersubstansen til indoxacarb, som derved omdannes til sin biologisk aktive form.
In the mid-gut of susceptible insect species, the insect’s enzymes remove the carbomethoxy group from parent indoxacarb, and convert it into its biologically active form.
I det neoadjuverende studie NEOSPHERE, hvor patienterne fik 4 serier Perjeta som neoadjuverende behandling, var hyppigheden af LVD (i den samlede behandlingsperiode) højere i gruppen behandlet med Perjeta, trastuzumab og docetaxel (7,5 %) sammenlignet med gruppen behandlet med trastuzumab og docetaxel (1,9 %).
In the neoadjuvant trial NEOSPHERE , in which patients received 4 cycles of Perjeta as neoadjuvant treatment, the incidence of LVD (during the overall treatment period) was higher in the Perjeta, trastuzumab and docetaxel-treated group (7.5%) compared to the trastuzumab and docetaxel-treated group (1.9%).
I det neoadjuverende studie TRYPHAENA var de hyppigste bivirkninger (≥ 50 %) neutropeni, diarré og kvalme når Perjeta blev administreret i kombination med trastuzumab og 5-fluoruracil, epirubicin, og cyclophosphamid i 3 serier efterfulgt af 3 serier med Perjeta, trastuzumab og docetaxel.
In the neoadjuvant trial TRYPHAENA, when Perjeta was administered in combination with trastuzumab and FEC (5-fluorouracil, epirubicin, cyclophosphamide) for 3 cycles followed by 3 cycles of Perjeta, trastuzumab and docetaxel, the most common ADRs (≥50%) were neutropenia, diarrhoea and nausea.
I det neoadjuverende studie TRYPHAENA var hyppigheden af LVD (i den samlede behandlingsperiode) 8,3 % i gruppen behandlet med Perjeta plus trastuzumab og 5-fluoruracil, epirubicin og cyclophosphamid (efterfulgt af Perjeta plus trastuzumab og docetaxel), 9,3 % i gruppen behandlet med Perjeta plus trastuzumab og docetaxel efter 5-fluoruracil, epirubicin og cyclophosphamid, og 6,6 % i gruppen behandlet med Perjeta i kombination med docetaxel, carboplatin og trastuzumab.
In the neoadjuvant trial TRYPHAENA, the incidence of LVD (during the overall treatment period) was 8.3% in the group treated with Perjeta plus trastuzumab and FEC (followed by Perjeta plus trastuzumab and docetaxel); 9.3% in the group treated with Perjeta plus trastuzumab and docetaxel following FEC; and 6.6% in the group treated with Perjeta in combination with TCH.
I det neoadjuvernede studie NEOSPHERE var de hyppigste bivirkninger (≥ 50 %) ved Perjeta i kombination med trastuzumab og docetaxel, alopeci og neutropeni.
In the neoadjuvant trial NEOSPHERE, the most common ADRs (≥50%) seen with Perjeta in combination with trastuzumab and docetaxel were alopecia and neutropenia.
I det pivotale dobbeltblindede ATLAS ACS 2 TIMI 51-studie blev 15.526 patienter randomiseret i forholdet 1:1:1 til en af tre behandlingsgrupper: Xarelto 2,5 mg oralt to gange dagligt, 5 mg oralt to gange dagligt eller til placebo to gange dagligt givet samtidig med ASA alene eller med ASA og en thienopyridin (clopidogrel eller ticlopidin).
In the pivotal double-blind ATLAS ACS 2 TIMI 51 trial, 15,526 patients were randomly assigned in a 1:1:1 fashion to one of three treatment groups: Xarelto 2.5 mg orally twice daily, 5 mg orally twice daily or to placebo twice daily co-administered with ASA alone or with ASA plus a thienopyridine (clopidogrel or ticlopidine).
I det pivotale fase 3-GIST-studie (n = 312) blev behandlingsrelaterede letale hjertebivirkninger rapporteret hos 1% af patienterne i den ene behandlingsgruppe i studiet (dvs. sunitinib og placebogruppen).
In the pivotal phase 3 GIST study (n = 312), treatment-related fatal cardiac reactions occurred in 1% of patients on each arm of the study (i.e. sunitinib and placebo arms).
I det pivotale Hokusai-VTE-studie blev 8.292 personer randomiseret til at få en indledende heparinbehandling (enoxaparin eller ufraktioneret heparin) efterfulgt af edoxaban 60 mg en gang dagligt eller det middel, der sammenlignes med.
In the pivotal Hokusai-VTE study, 8,292 subjects were randomised to receive initial heparin therapy (enoxaparin or unfractionated heparin) followed by edoxaban 60 mg once daily or the comparator.
I det pivotale ikke-dialysestudie 204 havde CKD ND-patienter, der blev behandlet med Fexeric, en signifikant forhøjelse af koncentrationen af TSAT, ferritin og hæmoglobin sammenlignet med placebogruppen efter 12 ugers behandling (p<0,001 for behandlingsforskel for hvert parameter) (tabel 4).
In the pivotal non-dialysis study 204 CKD ND patients treated with Fexeric had a significant increase in serum TSAT, ferritin and haemoglobin levels compared to the placebo group after 12 weeks of treatment (p< 0.001 for treatment difference for each parameter) (Table 4).
I det pivotale kliniske studie (N = 189) blev der indberettet alvorlige CRS-reaktioner hos 0,5 % af patienterne med en mediantid indtil hændelsernes indtræden på 2 dage.
In the pivotal clinical study (N = 189), serious CRS reactions were reported in 0.5% of patients with a median time to onset of 2 days.
I det pivotale kliniske studie (N = 189) blev der indberettet stigninger i leverenzymer hos 27,5 % af patienterne.
In the pivotal clinical study (N = 189), 27.5% of patients reported elevated liver enzymes.
I det pivotale kliniske studie (N = 189) blev under 1,4 % af de patienter, som blev behandlet med blinatumomab, testet positive for bindende og neutraliserende anti-blinatumomab-antistoffer.
In the pivotal clinical study (N = 189), less than 1.4% of patients treated with blinatumomab tested positive for binding and neutralising anti-blinatumomab antibodies.
I det pivotale kliniske studie (N = 189) fik 51,9 % af patienterne en eller flere neurologiske bivirkninger (herunder psykiske forstyrrelser), der primært involverede centralnervesystemet.
In the pivotal clinical study (N = 189), 51.9% of patients experienced one or more neurologic adverse reactions (including psychiatric disorders), primarily involving the central nervous system.
I det pivotale kliniske studie CLEOPATRA fik 408 patienter mindst én dosis Perjeta i kombination med trastuzumab og docetaxel.
In the pivotal clinical trial CLEOPATRA, 408 patients received at least one dose of Perjeta in combination with trastuzumab and docetaxel.