natgillin/translations-raw huggingface dataset:
Ikke almindelig Guillain Barré syndrom, polyneuropati, neuritis, peroneusparese, autoimmun neuropati (herunder facial og nervus abducens parese), encephalitisc polyneuropati, autoimmun neuropati (herunder facial og nervus abducens parese), myasthenia gravisc
Uncommon Guillain-Barré syndrome, polyneuropathy, neuritis, peroneal nerve palsy, autoimmune neuropathy (including facial and abducens nerve paresis), encephalitisc polyneuropathy, autoimmune neuropathy (including facial and abducens nerve paresis), myasthenia gravisc
Immunrelateret nefritis og nedsat nyrefunktion
Immune-related nephritis and renal dysfunction
Planocellulær NSCLC
Squamous NSCLC
CA209032 var et fase 1/2 ikke-blindet multikohorte studie, som omfattede en kohorte på 78 patienter (herunder 18 patienter, som overgik i følge studieprotokollen til behandling med en kombination af nivolumab 3 mg/kg plus ipilimumab 1 mg/kg) med tilsvarende inklusionskriterier som studie CA209275 behandlet med nivolumab-monoterapi 3 mg/kg for urothelialt karcinom.
CA209032 was a Phase 1/2 open-label multi-cohort study which included a cohort of 78 patients (including 18 subjects who received planned crossover treatment with nivolumab 3 mg/kg plus ipilimumab 1 mg/kg combination) with similar inclusion criteria to study CA209275 treated with nivolumab monotherapy 3 mg/kg for urothelial carcinoma.
Nivolumab 3 mg/kg (hændelser: 183/410), median-OS og 95 % CI: 25,00 (21,75; N.A.)
Nivolumab 3 mg/kg (events: 183/410), median and 95% CI: 25.00 (21.75, N.A.)
Niveauerne af PD-L1-tumorekspression var velbalancerede mellem de to behandlingsgrupper (nivolumab vs. investigators valg) ved hvert af de prædefinerede PD-L1-tumorekspressionsniveauer på ≥ 1 % (55 % vs. 62 %), ≥ 5 % (34 % vs. 43 %), og ≥ 10 % (27 % vs. 34 %).
Tumour PD-L1 expression levels were balanced between the two treatment groups (nivolumab vs. investigator's choice) at each of the predefined tumour PD-L1 expression levels of ≥ 1% (55% vs. 62%), ≥ 5% (34% vs. 43%), or ≥ 10% (27% vs.
Grad 2 hypopituitarisme forekom hos 0,4 % (2/547) af patienterne.
Grade 2 hypopituitarism occurred in 0.4% (2/547) of patients.
Randomiseret fase 3-studie med nivolumab versus ipilimumab 10 mg/kg (CA209238)
Randomised phase 3 study of nivolumab vs ipilimumab 10 mg/kg (CA209238)
Tabel 20: Patientkarakteristika ved baseline i CA209205 kohorte B, kohorte C og CA209039
Table 20: Baseline patient characteristics in CA209205 Cohort B, Cohort C and CA209039
4 % af patienterne havde hjernemetastaser i anamnesen, og 37 % af patienterne havde et laktatdehydrogenase (LDH)-niveau ved baseline, der var højere end ULN ved inklusion i studiet.
Four percent of patients had a history of brain metastasis, and 37% of patients had a baseline LDH level greater than ULN at study entry.
Infusionen skal administreres gennem et sterilt, pyrogenfrit, minimalt proteinbindende in-line filter med en porestørrelse på 0,2-1,2 μm.
The infusion must be administered through a sterile, non-pyrogenic, low protein binding in-line filter with a pore size of 0.2-1.2 μm.
Hvis du får OPDIVO sammen med ipilimumab, vil du få de første 4 doser som en infusion over en periode på 30 minutter med 3 ugers mellemrum (kombinationsfasen).
When OPDIVO is given in combination with ipilimumab, you will be given an infusion over a period of 30 minutes, every 3 weeks for the first 4 doses (combination phase).
OPDIVO som monoterapi er indiceret til adjuverende behandling af voksne med melanom, med lymfeknudeinvolvering eller metastatisk sygdom, som har fået foretaget komplet resektion (se pkt.
OPDIVO as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection (see section 5.1).
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) OPDIVO 10 mg/ml sterilt koncentrat nivolumab administreres i.v.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION OPDIVO 10 mg/mL sterile concentrate nivolumab
Grad 2 tilfælde blev rapporteret hos 2,4 % (13/547) af patienterne.
Grade 2 cases were reported in 2.4% (13/547) of patients.
Det primære effektparameter var ORR, bedømt af en IRRC.
The primary efficacy outcome measure was ORR as determined by an IRRC.
- - -*- - - - Nivolumab+ipilimumab (hændelser:161/314), median og 95 % CI: 11,50 (8,90; 22,18).
- - -*- - - - Nivolumab+ipilimumab (events: 161/314), median and 95% CI: 11.50 (8.90, 22.18).
c p-værdi blev sammenlignet med en alfa-værdi på 0,002 for at opnå statistisk signifikans.
c p-value is compared to alpha 0.002 in order to achieve statistical significance.
Brug af anden medicin sammen med OPDIVO
Other medicines and OPDIVO
Natriumcitratdihydrat Natriumchlorid
Sodium chloride
99,8 % CI p-værdib, c
Hazard ratioa 99.8% CI p-valueb, c
Muskuloskeletale smerter er en sammensat term, der omfatter rygsmerter, knoglesmerter, muskuloskeletale brystsmerter, muskuloskeletale gener, myalgi, nakkesmerter, smerter i arme og ben og smerter i rygsøjlen.
Musculoskeletal pain is a composite term which includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, myalgia, neck pain, pain in extremity, and spinal pain.
Resolution forekom hos 63 patienter (72,4 %) med en mediantid til resolution på 6,1 uger (0,1+-96,7+); + betegner en censureret observation.
Resolution occurred in 63 patients (72.4%) with a median time to resolution of 6.1 weeks (range: 0.1+-96.7+); + denotes a censored observation.
Nivolumab-monoterapi:
Nivolumab monotherapy:
Myocarditis skal i særdeleshed vurderes som en mulig diagnose.
The diagnosis of myocarditis requires a high index of suspicion.
f p-værdi blev sammenlignet med en alfa-værdi på 0,001 for at opnå statistisk signifikans.
f p-value is compared to alpha 0.001 in order to achieve statistical significance.
Betændelseslignende reaktion i nyrerne eller problemer med nyrerne.
Inflammation or problems with your kidneys.
Grad 3 thyroidearelaterede bivirkninger blev rapporteret hos < 0,1 % (2/2.578) af patienterne.
Grade 3 thyroid disorders were reported in < 0.1% (2/2578) of patients.
Blandt alle randomiserede patienter var ORR 27,2 % (95 % CI: 22,0, 32,9) i nivolumabgruppen og 9,8 % (95 % CI: 5,3, 16,1) i kemoterapigruppen.
Among all randomised patients, the ORR was 27.2% (95% CI: 22.0, 32.9) in the nivolumab group and 9.8% (95% CI: 5.3, 16.1) in the chemotherapy group.
Betændelse i hjernen
Inflammation of the brain
Tabel 23: Effektresultater (CA209141)
Table 23: Efficacy results (CA209141)
Tumorvurdering blev udført hver 12. uge, for de første 2 år, dernæst hver 6. måned.
Tumour assessments were conducted every 12 weeks for the first 2 years then every 6 months thereafter.
Hvis du får OPDIVO i kombination med ipilimumab, vil du få OPDIVO først og derefter ipilimumab.
When OPDIVO is given in combination with ipilimumab, you will first be given OPDIVO followed by ipilimumab.
Nivolumab eller nivolumab i kombination med ipilimumab skal seponeres permanent i tilfælde af enhver recidiverende alvorlig immunrelateret bivirkning og enhver livstruende immunrelateret bivirkning.
Nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued for any severe immune-related adverse reaction that recurs and for any life-threatening immune-related adverse reaction.
Behandlingen seponeres permanent Behandlingen seponeres permanent (se pkt.
Permanently discontinue treatment (see section 4.4)
ECOG-performance-score var 0 (73 %) eller 1 (27 %).
ECOG performance status score was 0 (73%) or 1 (27%).
CA209238-studiet
CA209238
Baseline ECOG-performance-status var 0 (54 %) eller 1 (46 %).
Baseline ECOG performance status was 0 (54%) or 1 (46%).
Når OPDIVO gives alene, er den anbefalede dosis enten 240 mg hver 2. uge eller 480 mg hver 4. uge, alt afhængig af indikationen.
When OPDIVO is given on its own, the recommended dose is either 240 mg given every 2 weeks or 480 mg given every 4 weeks depending on indication.
CA209205 er et igangværende åbent, enkelt-armet fase 2-studie af nivolumab ved klassisk HL med flere kohorter.
CA209205 is an ongoing Phase 2, open-label, multi-cohort, single-arm study of nivolumab in cHL.
For PD-L1-tumorekspression < 1 % var median-OS 34,7 måneder for nivolumab i kombination med ipilimumab, og den var 32,2 måneder for sunitinib-armen (HR = 0,70; 95 % CI: 0,54; 0,92).
For tumour PD-L1 expression < 1%, the median OS was 34.7 months for the nivolumab in combination with ipilimumab, and was 32.2 months in the sunitinib arm (HR = 0.70; 95% CI: 0.54, 0.92).
OPDIVO i kombination med ipilimumab er indiceret til førstelinjebehandling af voksne patienter med fremskredent renalcellekarcinom i mellem- eller højrisikogruppen (se pkt.
OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1).
Tabel 19: Effektresultater hos mellem- eller højrisikopatienter (CA209214)
Table 19: Efficacy results in intermediate/poor risk patients (CA209214)
Yderligere at undersøge værdien af biomarkører ud over PD-L1ekspressionsstatus ved tumorcellemembran-niveau ved immunhistokemisk (IHC) analyse (f.eks. andre metoder/analyser og relaterede cut-offs, som kan vise sig at være mere følsomme og specifikke til at forudse respons på behandlingen baseret på PD-L1 (på tumor- og tumerassocierede immunceller), PD-L2, tumorinfiltrerende lymfocytter med måling af CD8+T-densitet, RNA-signatur, tumormutationsbyrde), som prædiktive for effektiviteten af nivolumab som adjuverende behandling.
To further investigate the value of biomarkers other than PD-L1 expression status at tumour cell membrane level by IHC (e.g., other methods / assays, and associated cut offs, that might prove more sensitive and specific in predicting response to treatment based on PD-L1 (on tumour- and tumour associated immune cells), PD-L2, tumour infiltrating lymphocytes with measurement of CD8+T density, RNA signature, Tumour mutational burden) as predictive of nivolumab adjuvant therapy efficacy.
Randomiseret fase 2-studie med nivolumab i kombination med ipilimumab og ipilimumab (CA209069)
Randomised phase 2 study of nivolumab in combination with ipilimumab and ipilimumab (CA209069)
Grad 4 diarre eller colitis
Grade 4 diarrhoea or colitis
Investigatorvurderet ORR var 61 % (95 % CI: 48,9; 72,4) i kombinationsarmen (n = 72) versus 11 % (95 % CI: 3,0; 25,4) i ipilimumab-armen (n = 37).
Investigator assessed ORR was 61% (95% CI: 48.9, 72.4) in the combination arm (n = 72) versus 11% (95% CI: 3.0, 25.4) for the ipilimumab arm (n = 37).
Ledsmerter (artralgi), smerter i muskler og knogler (muskuloskeletale smerter) Træthed eller svaghedsfølelse, feber
Pain in the joints (arthralgia), pain in the muscles and bones (musculoskeletal pain) Feeling tired or weak, fever
27 % af patienterne havde tidligere fået et systemisk behandlingsregime, 51 % af patienterne havde fået 2 og 21 % af patienterne havde tidligere fået mere end 2 systemiske regimer.
The number of prior systemic regimen received was 1 for 27% of patients, 2 for 51% of patients, and > 2 for 21% of patients.
Bedre overlevelse blev observeret, uanset om patienterne havde tumorer, som var kategoriseret som PD-L1-negative eller PD-L1-positive (tumormembran-ekspression cut-off-niveau på 1 %, 5 % eller 10 %).
Survival benefit was observed regardless of whether patients had tumours that were designated PD-L1 negative or PDL1 positive (tumour membrane expression cut off of 1%, 5% or 10%).
OS-fordel blev observeret uanset PD-L1-tumorekspressionsniveau.
OS benefit was observed regardless of tumour PD-L1 expression level.
Den ordinerede dosis for patienten er 240 mg eller 480 mg uanset kropsvægt, alt afhængig af indikation (se pkt.
The prescribed dose for the patient is 240 mg or 480 mg given regardless of body weight depending on indication (see section 4.2).
Okulært/ uvealt melanom
Ocular/ Uveal melanoma
Ved 24 måneder var OS-raten 66,5 (95 % CI 61,8-70,9) for nivolumab i kombination med ipilimumab og 52,9 (95 % CI 47,9-57,7) for sunitinib.
At 24 months, the OS rate was 66.5 (95% CI 61.8-70.9) for nivolumab in combination with ipilimumab and 52.9 (95% CI 47.9- 57.7) for sunitinib.
Midlertidig betændelseslignende reaktion i nerverne, der medfører smerter, svaghed og lammelse af arme og ben (Guillain-Barré syndrom), tab af den beskyttende skede rundt om nerverne (demyelinisering), en tilstand, hvor musklerne bliver svage og hurtigere bliver trætte (myastenisk syndrom)
A temporary inflammation of the nerves that causes pain, weakness, and paralysis in the extremities (Guillain- Barré syndrome), loss of the protective sheath around nerves (demyelination), a condition in which the muscles become weak and tire easily (myasthenic syndrome)
Da der ikke foreligger tilstrækkelige data for patienter, som havde fået systemiske immunsuppressiva før studieinklusion, og for patienter med aktive hjernemetastaser eller leptomeningeale metastaser, bør nivolumab anvendes med forsigtighed hos disse populationer og kun efter omhyggelig afvejning af de potentielle fordele/risici for hver enkelt patient.
In the absence of data for patients who had been receiving systemic immunosuppressants prior to study entry, and for patients with active brain or leptomeningeal metastases, nivolumab should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis.
Medianalderen var 55 år (18-86) 58 % var mænd og 95 % var hvide.
The median age was 55 years (range: 18-86), 58% were men, and 95% were white.
Nivolumab er et humant immunglobulin G4 (IgG4) monoklonalt antistof (HuMAb), som bindes til programmeret celledød-1- (PD-1) receptor og blokerer dets interaktion med liganderne PD-L1 og PD-L2. PD-1-receptoren er en negativ regulator af T-celleaktivitet, som er vist at være medvirkende til at kontrollere T-celleimmunresponset.
Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2.
Tumorvurdering ifølge Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1, blev udført 9 uger efter randomisering og fortsatte hver 6. uge i det første år og herefter hver 12. uge.
Tumour assessments, according to the Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1, were conducted 9 weeks after randomisation and continued every 6 weeks for the first year and then every 12 weeks thereafter.
CA209172-studiet var et åbent enkeltarmsstudie med nivolumab som monoterapi til patienter med stadie III (inoperabelt) eller stadie IV metastatisk melanom efter tidligere behandling indeholdende et anti-CTLA-4 monoklonalt antistof.
Study CA209172 was a single-arm, open label study of nivolumab monotherapy in patients with stage III (unresectable) or stage IV metastatic melanoma after prior treatment containing an antiCTLA-4 monoclonal antibody.
Grad 3-4 immunrelaterede bivirkninger med antiCTLA-4
Grade 3-4 irAEs with Anti-CTLA-4
Grad 2 og grad 3 hypofysitis (inklusive lymfatisk hypofysitis) forekom hos henholdsvis 5,8 % (26/448) og 2,0 % (9/448) af patienterne.
Grade 2 and Grade 3 hypophysitis (including lymphocytic hypophysitis) occurred in 5.8% (26/448) and 2.0% (9/448) of patients, respectively.
24 ml koncentrat i et 25 ml hætteglas (type I-glas) med en prop (coated butylgummi) og et rødt mat flip-off låg (aluminium).
24 mL of concentrate in a 25 mL vial (Type I glass) with a stopper (coated butyl rubber) and a red matte flip-off seal (aluminium).
CA209171-studiet var et åbent enkeltarmsstudie med nivolumab som monoterapi til patienter med tidligere behandlet fremskreden eller metastatisk planocellulær NSCLC.
Study CA209171 was a single-arm, open label study of nivolumab monotherapy in patients with previously treated advanced or metastatic squamous NSCLC.
Nedsat antal røde blodlegemer (som transporterer ilt), hvide blodlegemer (som er vigtige for at kunne bekæmpe infektioner) eller blodplader (der hjælper blodet med at størkne) Øget mængde af enzymet, der nedbryder fedtstoffer, og af enzymet, der nedbryder stivelse Forhøjet eller nedsat mængde calcium eller kalium i blodet Forhøjet eller nedsat mængde magnesium eller natrium i blodet Vægttab
Abnormal kidney function tests (increased amounts of creatinine in your blood) High (hyperglycaemia) or low (hypoglycaemia) sugar levels in the blood A decreased number of red blood cells (which carry oxygen), white blood cells (which are important in fighting infection) or platelets (cells which help the blood to clot) An increased level of the enzyme that breaks down fats and of the enzyme that breaks down starch Increased or decreased amount of calcium or potassium Increased or decreased blood levels of magnesium or sodium Decrease in body weight
De første tumorvurderinger blev udført 9 uger efter behandlingsstart og fortsatte derefter indtil sygdomsprogression eller seponering.
The first tumour assessments were conducted 9 weeks after the start of treatment and continued thereafter until disease progression or treatment discontinuation.
Urothelialt karcinom CA209275 - et åbent fase 2 studie
Urothelial Carcinoma Open-label phase 2 study (CA209275)
Almindelig forhøjet total-bilirubin, hypoglykæmi, hypermagnesiæmi, hypernatriæmi, vægttab a
Common increased total bilirubin, hypoglycaemia, hypermagnesaemia, hypernatraemia, weight decreased a
Komplikationer ved allogen hæmatopoietisk stamcelletransplantation (HSCT) ved klassisk Hodgkins lymfom
Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT) in classical Hodgkin Lymphoma
Størstedelen af patienterne var kaukasiere (93 %) og mænd (76 %).
The majority of patients were white (93%) and male (76%).
≥ 1 % til < 10 %a
≥ 1% to < 10%a
I analyser af undergrupperne blev der ikke observeret bedre overlevelse sammenlignet med docetaxel for patienter, som aldrig havde røget, eller hvis tumorer indeholdt aktiverende EGFR-mutationer.
In subgroup analyses, survival benefit compared to docetaxel was not shown for patients who were never-smokers or whose tumours harboured EGFR activating mutations; however, due to the small numbers of patients, no definitive conclusions can be drawn from these data.
PD-L1-tumorekspression blev bestemt ved hjælp af PD-L1 IHC 288 pharmDx-analysen.
Tumour PD-L1 expression was determined using the PD-L1 IHC 288 pharmDx assay.
Nivolumab eller nivolumab i kombination med ipilimumab skal udsættes ved grad 3 udslæt og seponeres ved grad 4 udslæt.
Nivolumab or nivolumab in combination with ipilimumab should be withheld for Grade 3 rash and discontinued for Grade 4 rash.
Hos patienter, som blev behandlet med nivolumab-monoterapi, var hyppigheden af diarre, colitis eller hyppig afføring13,1 % (339/2.578).
In patients treated with nivolumab monotherapy, the incidence of diarrhoea, colitis, or frequent bowel movements was 13.1% (339/2578).
Omfanget af OS-fordelen var konsistent for PD-L1tumorekspressionsniveauerne ≥ 1 %, ≥ 5 % og ≥ 10 % (se tabel 24).
The magnitude of OS benefit was consistent for ≥ 1%, ≥ 5% or ≥ 10% tumour PD-L1 expression levels (see Table 24).
NE: ikke estimerbar
NE: non-estimable
Bedre overlevelse blev observeret, uanset om patienterne havde tumorer, som var kategoriseret som PD-L1-negative eller PD-L1-positive (tumormembranekspression cut-off-niveau på 5 % eller 10 %).
Survival benefit was observed regardless of whether patients had tumours that were designated PD-L1 negative or PD-L1 positive (tumour membrane expression cut off of 5% or 10%).
Den første tumorvurdring blev foretaget 8 uger efter påbegyndt behandling og fortsatte hver 8. uge derefter op til 48 uger, derefter hver 12. uge indtil sygdomsprogression eller afbrydelse af behandling, hvad end indtraf sidst.
The first tumour assessments were conducted 8 weeks after the start of treatment and continued every 8 weeks thereafter up to 48 weeks, then every 12 weeks until disease progression or treatment discontinuation, whichever occurred later.
Du får muligvis OPDIVO sammen med ipilimumab.
OPDIVO may be given in combination with ipilimumab.
Når der indtræder bedring, kan nivolumabmonoterapi genoptages efter nedtrapning af kortikosteroid.
Upon improvement, nivolumab monotherapy may be resumed after corticosteroid taper.
Hos patienter med PD-L1tumorekspression <1 % var ORR pr. IRRC henholdsvis 13,0 % (n=69 ; 95 % CI : 6,1, 23,3) og 12,0 % (n=25 ; 95 % CI : 2,5, 31,2).
In patients with tumour PD-L1 expression <1%, ORR per IRRC was 13.0% (n=69; 95% CI: 6.1, 23.3) and 12.0% (n=25; 95% CI: 2.5, 31.2), respectively.
Den observerede OS-fordel blev vist konsistent på tværs af forskellige undergrupper af patienter, inklusive ECOG-performance-score ved baseline, M-stadie, tidligere hjernemetastaser og LDH-niveau ved baseline.
The observed OS benefit was consistently demonstrated across subgroups of patients including baseline ECOG performance status, M stage, history of brain metastases, and baseline LDH level.
Ingen grad 3-5 tilfælde blev rapporteret.
No Grade 3-5 cases were reported.
Patienter med en performance-score ved baseline på 2, behandlede leptomeningeale metastaser, okulært/uvealt melanom eller autoimmun sygdom og patienter, som havde haft en grad 3-4 bivirkning, der var relateret til tidligere anti-CTLA-4-behandling, blev inkluderet i CA209172-studiet (se pkt.
Patients with baseline performance score of 2, treated leptomeningeal metastases, ocular/uveal melanoma, autoimmune disease and patients who have had a Grade 3-4 adverse reaction that was related to prior anti-CTLA-4 therapy were included in study CA209172 (see section 5.1).
Der skal anvendes et infusionssæt og et sterilt, pyrogenfrit, minimalt proteinbindende in-line filter (porestørrelse 0,2 μm til 1,2 μm).
Use an infusion set and an in-line, sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 μm to 1.2 μm).
Figur 11: Kaplan-Meier-kurverne for OS hos mellem- eller højrisikopatienter (CA209214)
Figure 11: Kaplan-Meier curves of OS in intermediate/poor risk patients (CA209214)
(61 nivolumab, 47 investigators valg)
(61 nivolumab, 47 investigator's choice)
Objektiv respons, n (%); (95 % CI) Komplet remission (CR), n (%); (95 % CI) Delvis remission (PR), n (%); (95 % CI) Stabil sygdom, n (%) Responsvarighed (måneder)b
Objective response, n (%); (95% CI) Complete remission (CR), n (%); (95% CI) Partial remission (PR), n (%); (95% CI) Stable disease, n (%) Duration of response (months)b Median (95% CI)
OPDIVO må ikke infunderes samtidigt med andre lægemidler i samme infusionsslange.
OPDIVO should not be infused concomitantly in the same intravenous line with other medicinal products.
Studiet inkluderede patienter (18 år og ældre), som havde sygdomsprogression under eller efter platinholdig kemoterapi for fremskreden eller metastatisk sygdom eller havde sygdomsprogression inden for 12 måneder efter neoadjuvant eller adjuvant behandling med platinholdig kemoterapi.
The study included patients (18 years or older) who had disease progression during or following platinum-containing chemotherapy for advanced or metastatic disease or had disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Diabetes mellitus inklusive Type 1 diabetes mellitus (3 grad 2, 2 grad 3 og 3 grad 4) og diabetisk ketoacidose (1 grad 4) blev rapporteret.
Diabetes mellitus including Type 1 diabetes mellitus (3 Grade 2, 2 Grade 3, and 3
Klassisk Hodgkins Lymfom
Classical Hodgkin lymphoma
Nedsat funktion af biskjoldbruskkirtlerne
Decreased function of the parathyroid gland
Adjuverende behandling af melanom (monoterapi):
- Adjuvant treatment of melanoma (monotherapy): study
34 % af patienterne havde PD-L1-tumorekspression ≥ 5 % og 62 % havde < 5 %, bestemt ved en klinisk studieanalyse.
For tumour PD-L1 expression, 34% of patients had PD-L1 expression ≥ 5% and 62% had < 5% as determined by clinical trial assay.
NE= ikke estimerbar
NE = non-estimable