natgillin/translations-raw huggingface dataset:
Den potentielle effekt af øgede plasmakoncentrationer af midazolam og andre benzodiazepiner, der metaboliseres via CYP3A4 (alprazolam, triazolam) bør tages i betragtning, når disse gives samtidigt med administration af et 3- dages (fos) aprepitantregime.
The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolised via CYP3A4 (alprazolam, triazolam) should be considered when co-administering these agents with a 3-day regimen of fosaprepitant followed by aprepitant.
En fosaprepitant- dosis på 100 mg indgivet over 15 minutter sammen med en enkelt dosis midazolam 2 mg øgede midazolams AUC 1, 6 gange.
Fosaprepitant given at a dose of 100 mg over 15 minutes with a single dose of midazolam 2 mg increased the AUC of midazolam 1.6-fold.
Peroral aprepitant øgede midazolams AUC 2, 3 gange på dag 1 og 3, 3 gange på dag 5, når en enkelt peroral midazolamdosis på 2 mg blev givet samtidig med aprepitant på dag 1 og 5 i et peroralt aprepitantregime med 125 mg på dag 1 og 80 mg/ dag på dag 2- 5.
Oral aprepitant increased the AUC of midazolam 2.3-fold on Day 1 and 3.3-fold on Day 5, when a single oral dose of midazolam 2 mg was co-administered on Days 1 and 5 of a regimen of oral aprepitant 125 mg on Day 1 and 80 mg/ day on Days 2 to 5.
I en anden undersøgelse med intravenøs administration af midazolam blev aprepitant givet peroralt som 125 mg på dag 1 og 80 mg/ dag på dag 2 og 3, og 2 mg midazolam blev givet intravenøst inden administration af 3- dages peroral aprepitantregime samt på dag 4, 8 og 15.
In another study with intravenous administration of midazolam, oral aprepitant was given as 125 mg on Day 1 and 80 mg/ day on Days 2 and 3, and midazolam 2 mg was given intravenously prior to the administration of the 3-day regimen of oral aprepitant and on Days 4, 8, and 15.
Peroral aprepitant øgede midazolams AUC med 25% på dag 4 og nedsatte midazolams AUC med 19% på dag 8 og 4% på dag 15.
Oral aprepitant increased the AUC of midazolam 25% on Day 4 and decreased the AUC of midazolam 19% on Day 8 and 4% on Day 15.
Disse virkninger ansås ikke for at være klinisk betydningsfulde.
These effects were not considered clinically important.
I en tredje undersøgelse med intravenøs og peroral administration af midazolam blev aprepitant givet peroralt som 125 mg på dag 1 og 80 mg/ dag på dag 2 og 3 sammen med ondansetron 32 mg på dag 1, dexamethason 12 mg på dag 1 og 8 mg på dag 2- 4.
In a third study with intravenous and oral administration of midazolam, oral aprepitant was given as 125 mg on Day 1 and 80 mg/ day on Days 2 and 3, together with ondansetron 32 mg Day 1, dexamethasone, 12 mg Day 1 and 8 mg Days 2-4.
Denne kombination (dvs. peroral aprepitant, ondansetron og dexamethason) nedsatte peroral midazolams AUC med 16% på dag 6, 9% på dag 8, 7% på dag 15 og 17% på dag 22.
This combination (i. e. oral aprepitant, ondansetron and dexamethasone) decreased the AUC of oral midazolam 16% on Day 6, 9% on Day 8, 7% on Day 15 and 17% on Day 22.
En fjerde undersøgelse blev udført med intravenøs administration af midazolam og peroral aprepitant.
A fourth study was completed with intravenous administration of midazolam and oral aprepitant.
Intravenøs midazolam 2 mg blev givet 1 time efter peroral administration af en enkelt peroral dosis aprepitant 125 mg.
Intravenous midazolam 2 mg was given 1 hour after oral administration of a single dose of oral aprepitant 125 mg.
Midazolams plasma- AUC øgedes 1, 5 gange.
The plasma AUC of midazolam was increased by 1.5-fold.
Denne virkning blev ikke anset for at være klinisk betydningsfuld.
This effect was not considered clinically important.
Der påvistes et lille klinisk relevant fald i blodtrykket, men ingen klinisk betydningsfuld ændring i hjertefrekvens eller PR- interval.
In patients with mild to moderate hypertension, infusion of 100 mg fosaprepitant over 15 minutes with diltiazem 120 mg 3 times daily, resulted in a 1.4-fold increase in diltiazem AUC and a small but clinically meaningful decrease in blood pressure, but did not result in a clinically meaningful change in heart rate, or PR interval.
4. 4).
In patients on chronic warfarin therapy, the prothrombin time (INR) should be monitored closely during treatment with fosaprepitant or aprepitant and for 2 weeks following each 3-day regimen for chemotherapy induced nausea and vomiting (see section 4.4).
Der sås imidlertid et 34% fald i S (-) warfarins (et CYP2C9- substrat) dalkoncentration fulgt af et fald på 14% i INR 5 dage efter afsluttet dosering med peroral aprepitant.
When a single 125 mg dose of oral aprepitant was administered on Day 1 and 80 mg/ day on Days 2 and 3 to healthy subjects who were stabilised on chronic warfarin therapy, there was no effect of oral aprepitant on the plasma AUC of R(+) or S(-) warfarin determined on Day 3; however, there was a 34% decrease in S(-) warfarin (a CYP2C9 substrate) trough concentration accompanied by a 14% decrease in INR 5 days after completion of dosing with oral aprepitant.
Når en enkelt dosis tolbutamid 500 mg blev indgivet peroralt inden administration af 3 dages behandlingsregime med peroral aprepitant samt på dag 4, 8 og 15, nedsatte aprepitant, administreret som 125 mg på dag 1 og 80 mg/ dag på dag 2 og 3, tolbutamids AUC (et CYP2C9 - substrat) med 23% på dag 4, 28% på dag 8 og 15% på dag 15.
Oral aprepitant, when given as 125 mg on Day 1 and 80 mg/ day on Days 2 and 3, decreased the AUC of tolbutamide (a CYP2C9 substrate) by 23% on Day 4, 28% on Day 8, and 15% on Day 15, when a single dose of tolbutamide 500 mg was administered orally prior to the administration of the 3-day regimen of oral aprepitant and on Days 4, 8, and 15.
6 Orale antikonceptiva:
Oral contraceptives:
Virkningen af hormonelle antikonceptiva kan være nedsat under behandling med peroral aprepitant og i 28 dage efter behandlingen.
The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of oral aprepitant.
Der bør anvendes alternative eller supplerende præventionsmetoder under behandling med fosaprepitant eller peroral aprepitant samt i 2 måneder efter sidste aprepitantdosis.
Alternative or back-up methods of contraception should be used during treatment with fosaprepitant or oral aprepitant and for 2 months following the last dose of aprepitant.
Når aprepitant gives én gang dagligt i 14 dage som en 100 mg kapsel sammen med oral antikonception indeholdende 35 μg ethinylestradiol og 1 mg norethindron, nedsattes AUC for ethinylestradiol med 43% og AUC for norethindron med 8%.
Aprepitant, when given once daily for 14 days as a 100 mg capsule with an oral contraceptive containing
I en anden undersøgelse blev der i 21 dage givet enkeltdoser peroral antikonception, indeholdende ethinylestradiol og norethindron.
6 35 μ g of ethinyl estradiol and 1 mg of norethindrone, decreased the AUC of ethinyl estradiol by 43%, and decreased the AUC of norethindrone by 8%.
Peroral aprepitant blev samtidigt givet som et regime med 125 mg på dag 8 og som 80 mg/ dag på dag 9 og 10 sammen med ondansetron 32 mg intravenøst på dag 8 og peroral dexamethason givet som 12 mg på dag 8 og som 8 mg/ dag på dag 9, 10 og 11.
In another study, single doses of an oral contraceptive containing ethinyl estradiol and norethindrone were administered on Days 1 through 21 withoral aprepitant, given as a regimen of 125 mg on Day 8 and 80 mg/ day on Days 9 and 10 with ondansetron 32 mg intravenously on Day 8 and oral dexamethasone given as 12 mg on Day 8 and 8 mg/ day on Days 9, 10, and 11.
I dette studie var der fra dag 9 til og med dag 21 op til 64% fald i dalkoncentrationen for ethinylestradiol og et fald på op til 60% i norethindrons dalkoncentration.
During days 9 through 21 in this study, there was as much as a 64% decrease in ethinyl estradiol trough concentrations and as much as a 60% decrease in norethindrone trough concentrations.
I kliniske interaktionsundersøgelser havde aprepitant ingen betydende klinisk indvirkning på farmakokinetikken for ondansetron, granisetron eller hydrodolasetron (dolasetrons aktive metabolit).
In clinical interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of ondansetron, granisetron, or hydrodolasetron (the active metabolite of dolasetron).
Andre lægemidlers indvirkning på aprepitants farmakokinetik Samtidig administration af (fos) aprepitant og lægemidler, som hæmmer CYP3A4- aktivitet (fx ritonavir, ketoconazol, clarithromycin, telithromycin) bør kun ske med forsigtighed, da kombinationen medfører forhøjede plasmakoncentrationer af aprepitant.
Effect of other agents on the pharmacokinetics of aprepitant Concomitant administration of fosaprepitant or aprepitant with medicinal products that inhibit CYP3A4 activity (e. g., ritonavir, ketoconazole, clarithromycin, telithromycin) should be approached cautiously, as the combination results in increased plasma concentrations of aprepitant.
Samtidig administration af (fos) aprepitant og lægemidler, som er stærke induktorer af CYP3A4 - aktivitet (fx rifampicin, phenytoin, carbamazepin, phenobarbital) bør undgås, da kombinationen medfører reducerede plasmakoncentrationer af aprepitant, hvilket kan resultere i nedsat virkning.
Concomitant administration of fosaprepitant or aprepitant with medicinal products that strongly induce CYP3A4 activity (e. g. rifampicin, phenytoin, carbamazepine, phenobarbital) should be avoided as the combination results in reductions of the plasma concentrations of aprepitant that may result in decreased efficacy.
3 gange.
When a single 125 mg dose of oral aprepitant was administered on Day 5 of a 10-day regimen of 400 mg/ day of ketoconazole, a strong CYP3A4 inhibitor, the AUC of aprepitant increased approximately 5-fold and the mean terminal half-life of aprepitant increased approximately 3-fold.
Infusion af 100 mg fosaprepitant over 15 minutter sammen med 120 mg diltiazem 3 gange dagligt medførte en stigning af aprepitants AUC på 1, 5 gange.
Infusion of 100 mg fosaprepitant over 15 minutes with diltiazem 120 mg 3 times daily, resulted in a 1.5-fold increase of aprepitant AUC.
Administration af 375 mg peroral aprepitant administreredes på dag 9 i et 14- dages behandlingsregime med rifampicin 600 mg/ dag, en stærk CYP3A4- inducer, medførte et fald i aprepitants AUC på 91% og et fald af den terminale gennemsnitshalveringstid faldt på 68%.
When a single 375 mg dose of oral aprepitant was administered on Day 9 of a 14-day regimen of 600 mg/ day of rifampicin, a strong CYP3A4 inducer, the AUC of aprepitant decreased 91% and the mean terminal half-life decreased 68%.
Der findes ingen kliniske data for gravide eksponeret for fosaprepitant og aprepitant.
For fosaprepitant and aprepitant no clinical data on exposed pregnancies are available.
Fosaprepitants og aprepitants mulige reproduktionstoksicitet er ikke tilstrækkeligt belyst, idet der i dyreundersøgelser ikke er opnået resultater for eksponering, der lå over de terapeutiske doser til mennesker.
The potential for reproductive toxicities of fosaprepitant and aprepitant have not been fully characterized, since exposure levels above the therapeutic exposure in humans were not attained in animal studies.
Aprepitant udskilles i mælken hos diegivende rotter både efter intravenøs administration af fosaprepitant og efter peroral administration af aprepitant.
Aprepitant is excreted in the milk of lactating rats after intravenous administration of fosaprepitant as well as after oral administration of aprepitant.
Derfor frarådes amning under behandling med IVEMEND og peroral aprepitant.
Therefore, breast-feeding is not recommended during treatment with IVEMEND and oral aprepitant.
4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
No studies on the effects of IVEMEND on the ability to drive and use machines have been performed.
7 Der er ikke foretaget undersøgelser af IVEMENDs virkning på evnen til at føre motorkøretøj eller betjene maskiner.
7 4.8 Undesirable effects
Da fosaprepitant omdannes til aprepitant, forventes de bivirkninger, der forbindes med aprepitant, også at forekomme med fosaprepitant.
Since fosaprepitant is converted to aprepitant, those adverse reactions associated with aprepitant are expected to occur with fosaprepitant.
4900 personer.
The safety profile of aprepitant was evaluated in approximately 4900 individuals.
Fosaprepitant er blevet administreret til i alt 729 personer, inklusive 347 raske forsøgspersoner og 149 patienter med CINV.
Various formulations of fosaprepitant have been administered to a total of 729 individuals including 347 healthy subjects and 149 patients with CINV.
17% af de patienter, der var i behandling med aprepitant sammenlignet med ca.
Adverse reactions considered as drug-related by the investigator were reported in approximately 17% of patients treated with the aprepitant regimen compared with approximately 13% of patients treated with standard therapy in patients receiving highly emetogenic chemotherapy.
Aprepitant blev seponeret på grund af bivirkninger hos ca.
Aprepitant was discontinued due to adverse reactions in 0.6% of patients treated with the aprepitant regimen compared with 0.4% of patients treated with standard therapy.
I en klinisk undersøgelse med patienter, som fik moderat emetogen kemoterapibehandling, blev der rapporteret om bivirkninger hos ca.
In a clinical study of patients receiving moderately emetogenic chemotherapy, clinical adverse reactions were reported in approximately 21% of patients treated with the aprepitant regimen compared with approximately 20% of patients treated with standard therapy.
20% af patienterne i standardbehandling.
Aprepitant was discontinued due to adverse reactions in 1.1% of patients treated with the aprepitant regimen compared with 0.5% of patients treated with standard therapy.
Hikke (4, 6%), asteni/ træthed (2, 9%), forhøjet ALAT (2, 8%), forstoppelse (2, 2%), hovedpine (2, 2%) og anorexi (2, 0%).
The most common adverse reactions reported at a greater incidence in patients treated with the aprepitant regimen than with standard therapy in patients receiving highly emetogenic chemotherapy were: hiccups (4.6%), asthenia/ fatigue (2.9%), ALT increased (2.8%), constipation (2.2%), headache (2.2%), and anorexia (2.0%).
Den mest almindelige bivirkning, der blev rapporteret med en højere incidens hos patienter i aprepitantbehandling end hos patienter i standardbehandling med moderat emetogen kemoterapi, var træthed (2, 5%).
The most common adverse reaction reported at a greater incidence in patients treated with the aprepitant regimen than with standard therapy in patients receiving moderately emetogenic chemotherapy was fatigue (2.5%).
Følgende bivirkninger blev observeret hos patienter i behandling med aprepitant og med en højere incidens end hos patienter i standardbehandling:
The following adverse reactions were observed in patients treated with the aprepitant regimen and at a greater incidence than with standard therapy:
Meget almindelig (≥1/ 10); almindelig (≥1/ 100, < 1/ 10); ikke almindelig (≥1/ 1000, < 1/ 100); sjælden (≥1/ 10. 000, < 1/ 1. 000) og meget sjælden (< 1/ 10. 000, ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000) and very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Forhøjet ALAT og ASAT.
ALT increased, AST increased.
Forhøjet basisk fosfatase, hyperglycæmi, mikroskopisk hæmaturi, hyponatriæmi, vægttab.
Uncommon: alkaline phosphatase increased, hyperglycaemia, microscopic haematuria, hyponatraemia, weight decreased.
Bradycardi.
Uncommon: bradycardia.
Ikke almindelig:
Blood and the lymphatic system disorders:
Anæmi, febril neutropeni.
Uncommon: anaemia, febrile neutropenia.
Almindelig:
Common: headache, dizziness.
Ikke almindelig:
Uncommon: dream abnormality, cognitive disorder.
Conjunctivitis.
Uncommon: conjunctivitis.
Tinnitus.
Uncommon: tinnitus.
8 Luftveje, thorax og mediastinum:
Respiratory, thoracic and mediastinal disorders:
Hikke.
Common: hiccups.
Pharyngitis, nysen, hoste, næseflåd, halsirritation.
Uncommon: pharyngitis, sneezing, cough, postnasal drip, throat irritation.
Ikke almindelig:
Gastrointestinal disorders:
Kvalme *, opkastning *, refluxgener, smagsforstyrrelser, ubehag i mellemgulvet, obstipation, gastroesophageal reflux, perforerende duodenalulcus, mavesmerter, mundtørhed, enterocolitis, flatulens, stomatitis.
8 Common: constipation, diarrhoea, dyspepsia, eructation Uncommon: nausea*, vomiting*, acid reflux, dysgeusia, epigastric discomfort, obstipation, gastroesophageal reflux disease, perforating duodenal ulcer, abdominal pain, dry mouth, enterocolitis, flatulence, stomatitis.
Ikke almindelig:
Renal and urinary disorders:
Polyuri, dysuri, pollakisuri.
Uncommon: polyuria, dysuria, pollakiuria.
Ikke almindelig:
Skin and subcutaneous tissue disorders:
Udslæt, acne, øget lysfølsomhed, øget svedtendens, fedtet hud, pruritus, hudlæsioner.
Uncommon: rash, acne, photosensitivity, hyperhidrosis, oily skin, pruritus, skin lesion.
Ikke almindelig:
Musculoskeletal and connective tissue disorders:
Muskelkramper, myalgi.
Uncommon: muscle cramp, myalgia.
Almindelig:
Common: anorexia.
Ikke almindelig:
Uncommon: weight gain, polydipsia.
Infektioner og parasitære sygdomme:
Infection and infestations:
Candidiasis, stafylokokinfektion.
Uncommon: candidiasis, staphylococcal infection.
Ikke almindelig:
Vascular disorders:
Flushing/ hedeture.
Uncommon: flushing/ hot flush.
Almindelig:
Common: asthaenia/ fatigue.
Ødemer, brystgener, lethargi, tørst.
Uncommon: oedema, chest discomfort, lethargy, thirst.
Ikke almindelig:
Psychiatric disorders:
Desorientering, eufori, angst.
Uncommon: disorientation, euphoria, anxiety.
* Kvalme og opkastning var effektparametre i de første 5 dage efter kemoterapibehandling og blev først derefter betragtet som bivirkninger.
*Nausea and vomiting were efficacy parameters in the first 5 days of post-chemotherapy treatment and were reported as adverse reactions only thereafter.
Bivirkningsprofilerne for gentagne kemoterapibehandlinger (multi- cyclus) og op til 5 behandlinger var generelt de samme, som for den første kemoterapibehandling.
The adverse reactions profiles in the Multiple-Cycle extension for up to 5 additional cycles of chemotherapy were generally similar to those observed in Cycle 1.
Desuden var induration og smerte på infusionsstedet almindelige bivirkninger i en bioækvivalensundersøgelse, hvor 66 forsøgspersoner fik 115 mg fosaprepitant intravenøst.
In addition, infusion site induration and infusion site pain were common adverse reactions in a bioequivalence study in which 66 subjects were dosed with 115 mg of fosaprepitant intravenously.
Øvre abdominalsmerter, abnorme tarmlyde, dysartri, dyspnø, hypoæstesi, søvnløshed, myosis, kvalme, sensorisk forstyrrelse, mavegener, nedsat synsskarphed, hvæsende vejrtrækning.
Additional adverse reactions were observed in patients treated with aprepitant (40 mg) for postoperative nausea and vomiting and a greater incidence than with ondansetron: abdominal pain upper, bowel sounds abnormal, dysarthria, dyspnoea, hypoaesthesia, insomnia, miosis, nausea, sensory disturbance, stomach discomfort, visual acuity reduced, wheezing.
Ét tilfælde af forstoppelse, og ét tilfælde af subileus.
In addition, two serious adverse reactions were reported in postoperative nausea and vomiting (PONV) clinical studies in patients taking a higher dose of aprepitant: one case of constipation, and one case of sub-ileus.
9 Der er hos en patient, som fik aprepitant i en non- CINV/ non- PONV undersøgelse, rapporteret om ét tilfælde af angioneurotisk ødem og urticaria som en alvorlig hændelse.
One case of angioedema and urticaria was reported as a serious adverse event in a patient receiving aprepitant in a non-CINV/ non-PONV study.
Der foreligger ingen specifik information vedrørende behandling af overdosering.
No specific information is available on the treatment of overdose.
Der er rapporteret om søvnighed og hovedpine hos én patient, som indtog 1. 440 mg aprepitant.
Drowsiness and headache were reported in one patient who ingested 1,440 mg of aprepitant.
Enkelte doser på op til 200 mg fosaprepitant tåltes generelt godt af raske forsøgspersoner.
Single doses up to 200 mg of fosaprepitant were generally well tolerated in healthy subjects.
3 ud af 33 forsøgspersoner, som fik 200 mg fosaprepitant, oplevede mild trombose på injektionsstedet.
Three out of 33 subjects receiving 200 mg of fosaprepitant experienced mild injection site thrombosis.
På grund af aprepitants antiemetiske virkning vil lægemiddelinduceret emesis sandsynligvis ikke være effektiv.
Because of the antiemetic activity of aprepitant, drug-induced emesis may not be effective.
ATC kode:
Antiemetics and antinauseants, ATC code:
5. 2).
Fosaprepitant is the prodrug of aprepitant and when administered intravenously is converted rapidly to aprepitant (see section 5.2).
Fosaprepitants farmakologiske effekt tilskrives aprepitant, idet en selvstændig effekt af fosaprepitant i den initiale fase ikke kan udelukkes.
The contribution of fosaprepitant to the overall antiemetic effect has not fully been characterized, but a transient contribution during the initial phase cannot be ruled out.
Aprepitant er en selektiv højaffinitets- antagonist på humane substans- P neurokinin- 1 (NK1) - receptorer.
Aprepitant is a selective high-affinity antagonist at human substance P neurokinin 1 (NK1) receptors.
4. 2) sammenlignet med et standardbehandlingsregime (placebo plus ondansetron 32 mg intravenøst dag 1 plus dexamethason 20 mg peroralt på dag 1 og 8 mg peroralt to gange dagligt dag 2- 4).
In 2 randomised, double-blind studies encompassing a total of 1,094 patients receiving chemotherapy that included cisplatin ≥ 70 mg/ m2, aprepitant in combination with an ondansetron/ dexamethasone regimen (see section 4.2) was compared with a standard regimen (placebo plus ondansetron 32 mg intravenously administered on Day 1 plus dexamethasone 20 mg orally on Day 1 and 8 mg orally twice daily on Days 2 to 4).
Resultaterne blev evalueret for hver enkelt undersøgelse og for de kombinerede data.
The results were evaluated for each individual study and for the 2 studies combined.
En opsummering af nøgleresultaterne fra den kombinerede analyse ses i tabel 1.
10 A summary of the key study results from the combined analysis is shown in Table 1.
Tabel 1 Patienter (%) med respons pr. behandlingsgruppe og fase - cyklus 1 Højemetogen kemoterapibehandling
Table 1 Percent of Patients Receiving Highly Emetogenic Chemotherapy Responding by Treatment Group and Phase — Cycle 1
behandlingsregime (N=521) †%
521 )†%
Standardbehandling (N=524) †%%
(N= 524 )†%%
Komplet respons (ingen emesis og ingen erstatningsterapi) Total (0- 120 timer) 0- 24 timer
Overall (0-120 hours) 0-24 hours 25-120 hours
67, 7 86, 0
67.7 86.0 71.5
47, 8 73, 2
47.8 73.2 51.2
19, 9 12, 7
19.9 12.7 20.3
(14, 0; 25, 8) (7, 9; 17, 6)
(14.0, 25.8) (7.9, 17.6) (14.5, 26.1)
10
INDIVIDUAL MEASURES No Emesis (no emetic episodes regardless of use of rescue therapy)
25- 120 timer
Overall (0-120 hours) 0-24 hours 25-120 hours
(16, 4; 28, 0) (8, 0; 17, 5) (17, 0; 28, 2)
(16.4, 28.0) (8.0, 17.5) (17.0, 28.2)
(1, 6; 12, 8) (1, 5; 12, 6)
(1.6, 12.8) (1.5, 12.6)
* Konfidensintervallerne (CI) er ikke korrigeret for køn og samtidig kemoterapibehandling, som var inkluderet i den primære analyse af odds ratio og logistiske modeller. † For én patient i aprepitantregimet var der kun data for den akutte fase, og patienten blev ekskluderet fra de totale og forsinkede faseanalyser; for én patient i standardregimet var der kun data for den forsinkede fase, og patienten blev ekskluderet fra de totale og forsinkede faseanalyser.
* The confidence intervals were calculated with no adjustment for gender and concomitant chemotherapy, which were included in the primary analysis of odds ratios and logistic models. † One patient in the Aprepitant Regimen only had data in the acute phase and was excluded from the overall and delayed phase analyses; one patient in the Standard Regimen only had data in the delayed phase and was excluded from the overall and acute phase analyses.