natgillin/translations-raw huggingface dataset:
Juni 2006 teilte SkyePharma PLC dem Ausschuss für Humanarzneimittel (CHMP) offiziell mit, dass das Unternehmen seinen Antrag für eine neue Indikation für DepoCyte 50 mg Injektionssuspension zur intrathekalen Behandlung der durch solide Tumoren verursachten neoplastischen Meningitis zurückzieht.
On 28 June 2006, SkyePharma PLC officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a new indication for DepoCyte 50 mg suspension for injection, in the intrathecal treatment of solid tumour neoplastic meningitis.
DepoCyte wird zur Behandlung der lymphomatösen Meningitis angewendet, einer Erkrankung, bei der die Zellen eines Lymphknotentumors in die Membranen eingedrungen sind, die das Nervensystem umgeben (Meninges – Hirn - und Rückenmarkshäute).
DepoCyte is used to treat lymphomatous meningitis: this is a condition where lymphoma tumour cells have spread to the membranes that surround the nervous system (meninges).
DepoCyte wird direkt in das Nervensystem, d. h. in den Raum zwischen den Hirn - und Rückenmarkshäuten, gespritzt (intrathekale Injektion).
DepoCyte is injected directly into the nervous system, in the space between the lining of the spinal cord and brain (intrathecal injection).
B.
DepoCyte was to be used in the treatment of solid tumour neoplastic meningitis: this is a disease where cancer cells, originally from a solid tumour (such as lung or breast cancer), spread to the membranes of the nervous system.
Krebszellen) aus der Gruppe der Antimetabolite.
It is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group of anti-metabolites.
Im Anschluss an das
Following CHMP opinion, it usually takes around 6 weeks for the European Commission to update the licence.
(44- 20) 74 18 84 00 Fax (44- 20) 75 23 71 29 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Gutachten des CHMP dauert es in der Regel 6 Wochen, bis die Europäische Kommission die Zulassung aktualisiert.
(44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What was the recommendation of the CHMP at that time?
Aufgrund der geprüften Daten bestanden seitens des CHMP zum Zeitpunkt der Rücknahme des Antrags Bedenken.
Based on the review of the data at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that DepoCyte could not be approved for the intrathecal treatment of solid tumour neoplastic meningitis.
Aus diesem Grund vertrat der CHMP zum Zeitpunkt der Rücknahme des Antrags die Ansicht, es sei nicht belegt worden, dass der Nutzen von DepoCyte bei der Behandlung der durch solide Tumoren verursachten neoplastischen Meningitis gegenüber den Risiken überwiegt.
Therefore, at the time of the withdrawal, the CHMP’ s view was that it had not been shown that the benefits of DepoCyte in the treatment of solid tumour neoplastic meningitis were greater that its risks.
„ Compassionate- Use “ - Programmen mit DepoCyte?
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with DepoCyte?
Das Unternehmen hat den CHMP darüber informiert, dass die Entscheidung keine Konsequenzen für Patienten hat, die an klinischen Studien oder „ Compassionate- Use “ - Programmen (Programmen, bei denen Ärzte ein Arzneimittel zur Behandlung einer bestimmten Erkrankung für einen ihrer Patienten beantragen können, bevor dieses Mittel vollständig genehmigt wurde) teilnehmen.
The company has informed the CHMP that the decision has no consequences for patients enrolled in clinical trials or compassionate use programmes.
Sollten Sie an einer klinischen Studie oder an einem derartigen “ Compassionate- Use ” - Programm teilnehmen und weitere Informationen zu Ihrer Behandlung benötigen, wenden Sie sich an Ihren behandelnden Arzt.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Es ergeben sich keine Konsequenzen für die Anwendung von DepoCyte in den Indikationen, für die es bereits zugelassen ist und bei denen das bekannte Nutzen - / Risikoprofil unverändert bleibt.
There are no consequences for DepoCyte’ s use in the indications for which it is already authorised, where the known benefit and risk remain unchanged.
EMEA/ 349175/ 2006 0. 1, CURRENT
EMEA/ 349192/ 2006 0.1, CURRENT
DepoCyte 50 mg injektionsvæske suspension.
DepoCyte 50 mg suspension for injection
Hvert 5 ml- hætteglas indeholder 50 mg cytarabin (10 mg/ ml).
Each 5 ml vial contains 50 mg cytarabine (10 mg/ ml).
Se afsnit 6. 1 for at få en fuldstændig liste over hjælpestoffer.
For a full list of excipients, see section 6.1.
En hvid til off- white suspension til injektion.
A white to off-white suspension for injection.
Til behandling af lymfomatøs meningitis er dosis for voksne 50 mg (ét hætteglas) indgivet intratekalt (lumbalpunktur eller intraventrikulært via et Ommaya- reservoir).
For the treatment of lymphomatous meningitis, the dose for adults is 50 mg (one vial) administered intrathecally (lumbar puncture or intraventricularly via an Ommaya reservoir).
Følgende regime anbefales til induktions -, konsoliderings - og vedligeholdelsesbehandling.
The following regimen of induction, consolidation and maintenance therapy is recommended:
Induktionsbehandling:
Induction therapy:
50 mg indgivet hver 14. dag, i 2 doser (uge 1 og 3).
50 mg administered every 14 days for 2 doses (weeks 1 and 3).
Konsolideringsbehandling:
Consolidation therapy:
50 mg indgivet hver 14. dag, i 3 doser (uge 5, 7 og 9) fulgt af endnu en dosis på 50 mg i uge 13.
50 mg administered every 14 days for 3 doses (weeks 5, 7 and 9) followed by an additional dose of 50 mg at week 13.
50 mg indgivet hver 28. dag i 4 doser (uge 17, 21, 25 og 29).
50 mg administered every 28 days for 4 doses (weeks 17, 21, 25 and 29).
DepoCyte skal indgives ved langsom injektion i løbet af 1- 5 minutter direkte i cerebrospinalvæsken (CSF) enten via et intraventrikulært reservoir eller ved direkte injektion i lumbalsækken.
DepoCyte is to be administered by slow injection over a period of 1-5 minutes directly into the cerebrospinal fluid (CSF) via either an intraventricular reservoir or by direct injection into the lumbar sac.
Efter indgift af via lumbal punktur anbefales det, at patienten instrueres i at ligge fladt ned i en time.
Following administration by lumbar puncture, it is recommended that the patient should be instructed to lie flat for one hour.
Patienterne bør påbegynde behandling med dexamethason 4 mg 2 gange daglig peroralt eller intravenøst i 5 dage, startende på dagen for DepoCyte injektionen.
Patients should be started on dexamethasone 4 mg twice daily orally or intravenously for 5 days beginning on the day of injection of DepoCyte.
DepoCyte skal anvendes som leveret; må ikke fortyndes (se afsnit 6. 2).
DepoCyte must be used as supplied; do not dilute (see section 6.2).
Hvis det vedvarer, skal DepoCyte - behandlingen afbrydes.
If it persists, treatment with DepoCyte should be discontinued.
2 Børn og unge
2 Children and adolescents
Sikkerheden og effekten hos børn er ikke tilstrækkeligt dokumenteret (se sektion 5. 1).
Safety and efficacy in children have not been adequately demonstrated (see section 5.1).
DepoCyte frarådes til brug hos børn og unge, indtil der foreligger yderligere oplysninger.
DepoCyte is not recommended for use in children and adolescents until further data become available.
Overfølsomhed overfor det aktive stof eller andre af indholdsstofferne.
Hypersensitivity to the active substance or to any of the excipients.
Patienter, der får DepoCyte, bør samtidig behandles med kortikosteroider (f. eks. dexamethason) for at lindre symptomerne på arachnoiditis (se afsnit 4. 8), som er en almindelig bivirkning.
Patients receiving DepoCyte should be concurrently treated with corticosteroids (e. g. dexamethasone) to mitigate the symptoms of arachnoiditis (see section 4.8), which is a common adverse reaction.
Arachnoiditis er et syndrom, der viser sig primært ved kvalme, opkastning, hovedpine og feber.
Arachnoiditis is a syndrome manifested primarily by nausea, vomiting, headache and fever.
Kemisk arachnoiditis kan være dødbringende, hvis den ikke behandles.
If left untreated, chemical arachnoiditis may be fatal.
Hovedpine, kvalme, opkastning og feber, og om de tidlige tegn og symptomer på neurotoksicitet.
Patients should be informed about the expected adverse reactions of headache, nausea, vomiting and fever, and about the early signs and symptoms of neurotoxicity.
Ved intratekal indgift har cytarabin været forbundet med kvalme, opkastning og alvorlig toksicitet i centralnervesystemet, herunder blindhed, myelopati samt anden neurologisk toksicitet, der i visse tilfælde førte til permanent neurologisk deficit.
Cytarabine, when administered intrathecally, has been associated with nausea, vomiting and serious central nervous system toxicity including blindness, myelopathy and other neurological toxicity sometimes leading to a permanent neurological deficit.
DepoCyte indgift i kombination med andre neurotoksiske kemoterapeutika eller med kraniel/ spinal strålebehandling kan forøge risikoen for neurotoksicitet.
Administration of DepoCyte in combination with other neurotoxic chemotherapeutic agents or with cranial/ spinal irradiation may increase the risk of neurotoxicity.
Hydrocephalus er også rapporteret, muligvis fremskyndet af arachnoiditis.
Hydrocephalus has also been reported, possibly precipitated by arachnoiditis.
Blokering af cerebrospinalvæskestrømmen kan resultere i øget koncentration af frit cytarabin i cerebrospinalvæsken med øget risiko for neurotoksicitet.
Blockage of CSF flow may result in increased free cytarabine concentrations in the CSF with increased risk of neurotoxicity.
Fortolkning af cerebrospinalvæskeundersøgelse efter DepoCyte indgift skal udføres omhyggeligt, da DepoCyte partikler ligner hvide blodlegemer i størrelse og udseende.
Since DepoCyte’ s particles are similar in size and appearance to white blood cells, care must be taken in interpreting CSF examination following DepoCyte administration.
Samtidig indgift af DepoCyte og andre intratekale antineoplastiske lægemidler indgivet intratekalt er ikke undersøgt.
3 Concomitant administration of DepoCyte with other antineoplastic agents administered by the intrathecal route has not been studied.
3 Samtidig intratekal indgift af cytarabin og andre intratekale cytotoksiske lægemidler kan eventuelt øge risikoen for neurotoksicitet.
Intrathecal co-administration of cytarabine with other cytotoxic agents may increase the risk of neurotoxicity.
Cytarabin kan imidlertid forårsage fosterskader, når det indgives under graviditet.
Teratology studies in animals have not been conducted with DepoCyte and there are no adequate and well controlled studies in pregnant women; however cytarabine can cause foetal harm when administered during pregnancy.
Derfor bør behandlingen ikke gives til fertile kvinder, før graviditet er udelukket og kvinderne bør rådes til at anvende sikker antikonception.
Therefore, women of childbearing potential should not receive the treatment until pregnancy is excluded and should be advised to use a reliable contraceptive method.
På grund af at cytarabin har et mutagent potentiale, som muligvis kunne inducere kromosomskader i humane spermatozoer, bør mænd i DepoCyte behandling og deres partnere rådes til at anvende en pålidelig antikonceptionsmetode.
Given that cytarabine has a mutagenic potential which could induce chromosomal damage in the human spermatozoa, males undergoing DepoCyte treatment and their partner should be advised to use a reliable contraceptive method.
Der er ikke rapporteret klare virkninger af DepoCyte behandling på evnen til at køre eller betjene maskiner.
There have been no reports explicitly relating to effects of DepoCyte treatment on the ability to drive or use machines.
På baggrund af rapportede bivirkninger bør patienterne dog frarådes at køre eller betjene maskiner under behandlingen.
However, on the basis of reported adverse reactions, patients should be advised against driving or using machines during treatment.
DepoCyte kan potentielt forårsage alvorlig toksicitet.
DepoCyte has the potential of producing serious toxicity.
Alle patienter i DepoCyte behandling bør samtidig behandles med kortikosteroider (f. eks. dexamethason) for at lindre symptomerne på arachnoiditis.
All patients receiving DepoCyte should be treated concurrently with corticosteroids (e. g., dexamethasone) to mitigate the symptoms of arachnoiditis.
Toksiske virkninger kan være relaterede til en enkelt dosis eller til kumulerede doser.
Toxic effects may be related to a single dose or to cumulative doses.
Da toksiske virkninger kan opstå når som helst under behandlingen (selvom det er mest sandsynligt indenfor 5 dage efter indgift), bør patienter, der får DepoCyte behandling, kontrolleres kontinuerligt for udvikling af neurotoksicitet.
Because toxic effects can occur at any time during therapy (although they are most likely within 5 days of administration), patients receiving DepoCyte therapy should be monitored continuously for the development of neurotoxicity.
Hvis patieterne udvikler neurotoksicitet, bør efterfølgende DepoCyte doser reduceres og DepoCyte bør seponeres, hvis toksiciteten vedvarer.
If patients develop neurotoxicity, subsequent doses of DepoCyte should be reduced, and DepoCyte should be discontinued if toxicity persists.
Arachnoiditis, et syndrom, der primært manifesteres ved hovedpine, kvalme, opkastning, feber, stivhed i nakken, smerter i nakke eller ryg, meningisme, kramper, hydrocephalus, CSF pleocytosis med eller uden ændret bevidsthedstilstand, er en almindeligt forekommende bivirkning.
Arachnoiditis, a syndrome manifested primarily by headache, nausea, vomiting, fever, neck rigidity, neck or back pain, meningism, convulsions, hydrocephalus, CSF pleocytosis, with or without altered state of consciousness, is a common adverse reaction.
Arachnoiditis kan være dødelig, hvis den lades ubehandlet.
Arachnoiditis can be fatal if left untreated.
Forekomsten af bivirkninger, der muligvis afspejler meningeal irritation, konstateret hos patienter, der blev behandlet med 50 mg DepoCyte i kliniske fase II- IV- forsøg, fremgår af Tabel 1 nedenfor:
The incidence of adverse reactions possibly reflecting meningeal irritation determined from all the patients treated with 50 mg DepoCyte in the Phase II-IV clinical trials is given in Table 1 below:
4 Tabel 1:
4 Table 1:
Bivirkninger, der muligvis afspejler meningeal irritation hos patienter i fase II, III og IV (n [%] af behandlingsperioder *)
Adverse reactions possibly reflecting meningeal irritation in Phase II, III, and IV patients (n [%] of cycles* of therapy)
MedDRA- betegnelse
MedDRA preferred term
(n = 258
DepoCyte
(n = 99 perioder)
Methotrexate
perioder)
Cytarabine
Hovedpine NOS Kvalme Opkastning NOS Arachnoiditis Feber Rygsmerter Krampe NOS Nakkesmerter Nakkestivhed Hydrocephalus erhvervet CSF pleocytose Meningismus
Headache NOS Nausea Vomiting NOS Arachnoiditis Pyrexia Back pain Convulsions NOS Neck pain Neck stiffness Hydrocephalus acquired CSF Pleocytosis Meningism
24% 18% 17% 16% 12% 7% 6% 4% 3% 2% 1% < 1%
(n = 929 cycles) 24% 18% 17% 16% 12% 7% 6% 4% 3% 2% 1% < 1%
16% 12% 11% 7% 7% 7% 5% 3% < 1% 1% 0% 1%
(n = 258 cycles) 16% 12% 11% 7% 7% 7% 5% 3% < 1% 1% 0% 1%
14% 15% 11% 13% 16% 6% 2% 3% 4% 0% 0% 1%
99 cycles) 14% 15% 11% 13% 16% 6% 2% 3% 4% 0% 0% 1%
* Perioderne var på 2 uger, hvor patienten modtog enten 1 dosis DepoCyte eller 4 doser cytarabin eller methotrexat.
*Cycle length was 2 weeks during which the patient received either 1 dose of DepoCyte or 4 doses of cytarabine or methotrexate.
Cytarabin - og methotrexatpatienter, der ikke gennemførte alle 4 doser, er talt som en del af en periode.
Cytarabine and methotrexate patients not completing all 4 doses are counted as a fraction of a cycle.
Tabel 2 nedenfor viser hyppigheden af alle bivirkninger, der forekom i > 10% af perioderne i hver behandlingsgruppe i fase 1- 4- forsøg hos patienter med lymfomatøs meningitis, som modtog DepoCyte eller cytarabin:
The incidence of all adverse reactions occurring in > 10% of cycles in either treatment group in Phase 1-4 studies in patients with lymphomatous meningitis receiving DepoCyte or cytarabine is given in Table 2 below:
Tabel 2:
Table 2.
Bivirkninger, der forekom i > 10% af perioderne i hver behandlingsgruppe i fase 1- 4 forsøgspatienter med lymfomatøs meningitis, der modtog DepoCyte 50 mg eller cytarabin (% af behandlingsperioder *) Antal perioder
Adverse reactions occurring in > 10% of cycles in either treatment group in Phase 1- 4 study patients with lymphomatous meningitis receiving DepoCyte 50 mg or cytarabine (% of cycles* of therapy) Number of cycles
MedDRA- betegnelse
MedDRA Preferred Term
(n = 151 perioder)
(n=151 cycles)
(n = 99 perioder)
(n=99 cycles)
Sygdomme i nervesystemet
Nervous System Disorders
Hovedpine NOS Arachnoiditis Konfusion
Headache NOS Arachnoiditis Confusion
Kvalme Opkastning NOS Diarré NOS
Nausea Vomiting NOS Diarrhoea NOS
Generelle sygdomme og tilstande på indgiftsstedet
General Disorders and Administrative Site Conditions
Svaghed Feber Træthed
Weakness Pyrexia Fatigue
Sygdomme i blod og lymfesystem
Blood and Lymphatic System Disorders
* Induktions - og vedligeholdelsesperioderne var henholdsvis 2 og 4 uger, hvor patienten modtog enten 1 dosis DepoCyte eller 4 doser cytarabin.
*Induction and Maintenance cycle lengths were 2 and 4 weeks, respectively, during which the patient received either 1 dose of DepoCyte or 4 doses of cytarabine.
Cytarabinpatienter, der ikke gennemførte alle 4 doser inden for en periode, er talt som en hel periode.
Cytarabine patients not completing all 4 doses within a cycle are counted as a complete cycle.
Intratekal indgift af cytarabin kan eventuelt medføre myelopati og anden neurologisk toksicitet, der i nogle tilfælde fører til permanent neurologisk deficit.
Intrathecal administration of cytarabine may cause myelopathy and other neurologic toxicity sometimes leading to a permanent neurological deficit.
Efter intratekal indgift af DepoCyte er der rapporteret alvorlig toksicitet i centralnervesystemet, herunder vedvarende ekstrem somnolens, konfusion, halvsidig lammelse, synsforstyrrelser, herunder blindhed, samt døvhed og kranienerveparese.
Following intrathecal administration of DepoCyte, serious central nervous system toxicity, including persistent extreme somnolence, confusion, hemiplegia, visual disturbances including blindness, deafness and cranial nerve palsies have been reported.
Symptomer og tegn på perifer neuropati, f. eks. smerter, følelsesløshed, paræstesi, hypoæstesi, svækkelse og nedsat tarm - og blærekontrol (inkontinens) er også observeret.
Symptoms and signs of peripheral neuropathy, such as pain, numbness, paresthesia, hypoaesthesia, weakness, and impaired bowel and bladder control (incontinence) have also been observed.
5 Bivirkninger, som hyppigt forbindes med DepoCyte, er hovedpine, arachnoiditis og konfusion.
5 Adverse reactions more commonly associated with DepoCyte are headache, arachnoiditis and confusion.
Desuden var forekomsten af krampeanfald hos patienterne i fase 1- 4- forsøg højere i DepoCyte - gruppen (7/ 33, 21%) end i cytarabin- gruppen (1/ 28, 4%).
In addition, in Phase 1-4 studies, the patient incidence of convulsions was higher in the DepoCyte group (7/ 33, 21%) than in the cytarabine group (1/ 28, 4%).
Forbigående stigning af protein og hvide blodlegemer i cerebrospinalvæsken er også observeret hos patienter efter DepoCyte indgift og er også bemærket efter intratekal behandling med methotrexat og cytarabin.
Transient elevations in CSF protein and white blood cells have also been observed in patients following DepoCyte administration and also been noted after intrathecal treatment with methotrexate or cytarabine.
Overdosering af DepoCyte kan være forbundet med svær arachnoiditis heri medregnet encephalopati.
An overdose with DepoCyte may be associated with severe arachnoiditis including encephalopathy.
I et tidligt ukontrolleret studie uden dexamethason- profylakse, blev der indgivet enkeltdoser op til 125 mg.
In an early uncontrolled study without dexamethasone prophylaxis, single doses up to 125 mg were administered.
Udskiftning af cerebrospinalvæsken med isotonisk saltvand er udført i et tilfælde med intratekal overdosis af frit cytarabin og en sådan procedure kan overvejes i tilfælde af DepoCyte overdosering.
Exchange of cerebrospinal fluid with isotonic saline has been carried out in a case of intrathecal overdose of free cytarabine and such a procedure may be considered in the case of DepoCyte overdose.
Antimetabolit (pyrimidin- analog), ATC kode L01B C01
Antimetabolite (pyrimidine analogue), ATC code L01B C01
Cytarabin er et cellecyklusfase specifikt antineoplastisk middel, som kun påvirker celler i løbet af celledelingens S- fase.
Cytarabine is a cell-cycle phase specific antineoplastic agent, affecting cells only during the S-phase of cell division.
Cytarabin omdannes intracellulært til den aktive metabolit, cytarabin- 5 - triphosphat (ara- CTP).
Intracellularly, cytarabine is converted into cytarabine-5’ -triphosphate (ara-CTP), which is the active metabolite.
Virkningsmekanismen er ikke fuldt forstået, men det tyder på, at ara- CTP primært virker ved hæmning af DNA syntese.
The mechanism of action is not completely understood, but it appears that ara-CTP acts primarily through inhibition of DNA synthesis.
Eksponeringsvarigheden af cytotoksiske koncentrationer på neoplastiske celler er vigtig for lægemiddeleffekten af cellecyklusfase- specifikke antimetabolitter.
For cell-cycle phase specific antimetabolites the duration of exposure of neoplastic cells to cytotoxic concentrations is an important determination of drug efficacy.
10 μM (2, 4 μg/ ml) ved 2 dages påvirkning og 0, 1 μM (0, 024 μg/ ml) ved 6 dages påvirkning.
In vitro studies, examining more than 60 cell lines, demonstrated that the median cytarabine concentration resulting in 50% growth inhibition (IC50) was approximately 10 μ M (2.4 μ g/ ml) for two days of exposure and 0.1 μ M (0.024 μ g/ ml) for 6 days of exposure.
Studierne viste også at mange massive tumorcelle- linier var følsomme overfor cytarabin specielt efter længere tids påvirkning af cytarabin.
The studies also demonstrated susceptibility of many solid tumour cell lines to cytarabine, particularly after longer periods of exposure to cytarabine.
I en åben aktivt kontrolleret, klinisk multicenterundersøgelse blev 35 patienter med lymfomatøs meningitis (med maligne celler fundet ved spinalvæske cytologi) randomiseret til intratekal behandling med enten DepoCyte (n=18) eller uindkapslet cytarabin (n=17).
In an open-label, active-controlled, multicentre clinical study, 35 patients with lymphomatous meningitis (with malignant cells found on CSF cytology) were randomised to intrathecal therapy with either DepoCyte (n=18) or unencapsulated cytarabine (n=17).
De patienter, som opnåede respons (defineret som svind af maligne celler fra spinalvæsken i fravær af progression af neurologiske symtomer), fortsatte med at få konsoliderings - og vedligeholdelsesbehandling i op til 29 uger.
6 absence of progression of neurological symptoms) went on to receive Consolidation and Maintenance therapy for up to 29 weeks.
6 Respons blev observeret hos 13/ 18 (72%, 95% sikkerhedsintervaller:
Responses were observed in 13/ 18 (72%, 95% confidence intervals:
47, 90) af DepoCyte patienterne versus 3/ 17 (18% patienter, 95% sikkerhedsintervaller:
47, 90) of DepoCyte patients versus 3/ 17 (18% patients, 95% confidence intervals:
4, 43) i den uindkapslede arm.
4, 43) in the unencapsulated cytarabine arm.
En statistisk signifikant sammenhæng mellem behandling og respons blev observeret (Fisher’ s eksakte test p - værdi= 0, 002).
A statistically significant association between treatment and response was observed (Fisher’ s exact test p-value = 0.002).