FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the 137 patients, 134 patients received hormone replacement therapy and two patients received high-dose corticosteroids (at least 40 mg prednisone or equivalent per day) for hypothyroidism followed by hormone replacement.
Danish: Af de 137 patienter fik 134 patienter hormonsubstitutionsbehandling, og to patienter fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag) for hypothyreoidisme efterfulgt af hormonsubstitution.
English: Forest plot of PFS by PD-L1 expression
Danish: Forest-plot af PFS ved PD-L1-ekspression
English: • inflammation of the gut or intestine (colitis)
Danish: • betændelse i tarmen (colitis)
English: Mild (creatinine clearance (CrCL) 60 to 89 mL/min) and moderate renal impairment (creatinine clearance (CrCL) 30 to 59 mL/min) had no clinically significant effect on the PK of durvalumab.The effect of severe renal impairment (CrCL 15 to 29 mL/min) on the PK of durvalumab is unknown.
Danish: Let (kreatininclearance (CrCL) 60 til 89 ml/min) og moderat nedsat nyrefunktion (kreatininclearance (CrCL) 30 til 59 ml/min) havde ingen klinisk signifikant virkning på farmakokinetikken af durvalumab.
English: • Discard any unused portion left in the vial.
Danish: • Kassér eventuelt ubrugt lægemiddel, som er tilbage i hætteglasset.
English: Mild hepatic impairment (bilirubin ≤ ULN and AST > ULN or bilirubin > 1.0 to 1.5 × ULN and any AST) had no clinically significant effect on the PK of durvalumab.
Danish: Let nedsat leverfunktion (bilirubin ≤ ULN og ASAT > ULN eller bilirubin >1,0 til 1,5 × ULN og enhver ASAT) havde ingen klinisk signifikant virkning på farmakokinetikken af durvalumab.
English: The median time to onset was 95 days (range: 28-239 days).
Danish: Mediantiden til debut var 95 dage (interval: 28-239 dage).
English: • inflammation of the liver: symptoms may include nausea or vomiting, feeling less hungry, pain on the right side of your stomach, yellowing of skin or whites of eyes, drowsiness, dark urine or bleeding or bruising more easily than normal;
Danish: • betændelse i leveren: Symptomerne kan omfatte kvalme eller opkastning, at føle sig mindre sulten, smerter i højre side af maven, gulfarvning af huden eller det hvide i øjnene, døsighed, mørk urin eller blødning eller at have lettere ved at få blå mærker end normalt
English: Patients should be monitored for clinical signs and symptoms of hypophysitis or hypopituitarism.
Danish: Patienterne bør monitoreres for kliniske tegn og symptomer på hypofysitis eller hypopituitarisme.
English: Immune-mediated pneumonitis/interstitial lung disease
Danish: Immunmedieret pneumonitis/interstitiel lungesygdom
English: Immune-mediated hepatitis should be managed as recommended in section 4.2.
Danish: Immunmedieret hepatitis bør behandles som anbefalet i pkt.
English: p includes autoimmune nephritis, tubulointerstitial nephritis, nephritis, glomerulonephritis and glomerulonephritis membranous.
Danish: p omfatter autoimmun nefritis, tubulointerstitiel nefritis, nefritis, glomerulonefritis og membranøs glomerulonefritis.
English: Infusion related reactions should be managed as recommended in section 4.2
Danish: Infusionsrelaterede reaktioner skal behandles som anbefalet i pkt.
English: • inflammation of the lungs (pneumonitis)
Danish: • betændelsestilstand i lungerne (pneumonitis)
English: All 7 patients received systemic corticosteroids; 2 of the 7 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Danish: Alle 7 patienter fik systemisk kortikosteroid; 2 af de 7 patienter fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag).
English: Discard the vial if the solution is cloudy, discoloured or visible particles are observed.
Danish: Kassér hætteglasset, hvis opløsningen er uklar, misfarvet eller synlige partikler observeres.
English: The other ingredients are: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 80, water for injections.
Danish: Øvrige indholdsstoffer: histidin, histidinhydrochloridmonohydrat, trehalosedihydrat, polysorbat 80, vand til injektionsvæsker.
English: In the placebo group, 11 of the 16 patients received systemic corticosteroids, including 9 patients who received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Danish: I placebogruppen fik 11 ud af 16 patienter systemiske kortikosteroider, inklusive 9 patienter, der fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag).
English: Resolution occurred in 18 patients.
Danish: Resolution forekom hos 18 patienter.
English: • painful urination
Danish: • smertefuld vandladning
English: h frequency is based on events not observed in the PACIFIC Study but observed in AstraZeneca clinical trials (n=4067).
Danish: frekvensen er baseret på hændelser, der ikke blev observeret i PACIFIC studiet, men observeret i AstraZeneca kliniske studier (n=1889).
English: Resolution occurred in 23 patients.
Danish: Resolution forekom hos 23 patienter.
English: The median time to onset was 85 days (range: 9-378 days).
Danish: Mediantiden til debut var 85 dage (interval: 9-378 dage).
English: In the PACIFIC Study, (n = 475 in the IMFINZI arm, and n = 234 in the placebo arm) immune-mediated pneumonitis occurred in 51 (10.7%) patients in the IMFINZI-treated group and 16 (6.8%) patients in the placebo group, including Grade 3 in 8 (1.7%) patients on IMFINZI vs. 6 (2.6%) patients on placebo and Grade 5 (fatal) in 4 (0.8%) patients on IMFINZI vs. 3 (1.3%) patients on placebo.
Danish: I PACIFIC-studiet (n = 475 i IMFINZI-armen og n = 234 i placeboarmen) forekom immunmedieret pneumonitis hos 51 (10,7 %) patienter i gruppen, der fik IMFINZI, og hos 16 (6,8 %) patienter i placebogruppen, inklusive Grad 3 hos 8 (1,7 %) patienter, der fik IMFINZI, versus 6 (2,6 %) patienter, der fik placebo, og Grad 5 (letal) hos 4 (0,8 %) patienter, der fik IMFINZI versus 3 (1,3 %) patienter, der fik placebo.
English: The median time to onset was 141 days (range: 70-265 days).
Danish: Mediantiden til debut var 141 dage (interval: 70-265 dage).
English: Resolution occurred in 13 patients.
Danish: Resolution forekom hos 13 patienter.
English: Initiate 1 to 2 mg/kg/day prednisone or equivalent followed by a taper and hormone replacement as clinically indicated
Danish: Initiér 1-2 mg/kg/dag prednison eller tilsvarende, efterfulgt af nedtrapning og hormonsubstitutionsbehandling som klinisk indiceret
English: Hypothyroidism and hyperthyroidism
Danish: Hypothyreoidisme og hyperthyreoidisme
English: Resolution occurred in 1 patient.
Danish: Resolution forekom hos én patient.
English: Resolution occurred in 2 patients.
Danish: Resolution forekom hos 2 patienter.
English: For symptomatic adrenal insufficiency, patients should be managed as recommended in section 4.2.
Danish: Ved symptomatisk adrenal insufficiens bør patienter behandles som anbefalet i pkt.
English: Hepatobiliary disorders Aspartate aminotransferase increased or Alanine aminotransferase increased
Danish: Lever og galdeveje Forhøjet aspartataminotransferase eller forhøjet alaninaminotransferase
English: • swelling of the legs (oedema peripheral)
Danish: • hævelse af benene (perifere ødemer)
English: In the IMFINZI-treated group, 44 of the 51 patients received systemic corticosteroids, including 28 patients who received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day), and 2 patients also received infliximab.
Danish: I gruppen, der fik IMFINZI, fik 44 ud af 51 patienter systemiske kortikosteroider, inklusive 28 patienter, der fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag) og 2 patienter fik også infliximab.
English: For symptomatic hypophysitis or hypopituitarism, patients should be managed as recommended in section 4.2.
Danish: Ved symptomatisk hypofysitis eller hypopituitarisme bør patienterne behandles som anbefalet i pkt.
English: Other medicines and IMFINZI
Danish: Brug af anden medicin sammen med IMFINZI
English: Severe infusion related reactions have been reported in patients receiving IMFINZI (see section 4.8).
Danish: Alvorlige infusionsrelaterede reaktioner er blevet rapporteret hos patienter, der fik IMFINZI (se pkt.
English: IMFINZI was discontinued in 26 patients.
Danish: IMFINZI blev seponeret hos 26 patienter.
English: Excipients: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 80, water for injections.
Danish: Hjælpestoffer: histidin, histidinhydrochloridmonohydrat, trehalosedihydrat, polysorbat 80, vand til injektionsvæsker.
English: The median time to onset was 70 days (range: 15-312 days).
Danish: Mediantiden til debut var 70 dage (interval: 15-312 dage).
English: Patients should be monitored for abnormal liver tests prior to and periodically during treatment with IMFINZI, and as indicated based on clinical evaluation.
Danish: Patienterne bør monitoreres for unormale leverprøver før og periodisk under behandling med IMFINZI, og som indiceret på baggrund af klinisk vurdering.
English: • Infusion-related reactions: symptoms may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing dizziness, or fever.
Danish: • infusionsrelaterede reaktioner: Symptomerne kan omfatte kuldefornemmelse eller rysten, kløe eller udslæt, rødme, åndenød eller hvæsende vejrtrækning, svimmelhed eller feber.
English: IMFINZI is clear to opalescent, colourless to slightly yellow solution.
Danish: IMFINZI er en klar til opaliserende, farveløs til svagt gul opløsning.
English: 2.4 mL of concentrate in a Type 1 glass vial with an elastomeric stopper and a gray flip-off aluminium seal containing 120 mg durvalumab.
Danish: 2,4 ml koncentrat i et Type 1-hætteglas med en elastomerprop og en grå afrivelig aluminiumsforsegling indeholdende 120 mg durvalumab.
English: Forty-five of the 79 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day), and 2 patients also received infliximab.
Danish: 45 ud af 79 patienter fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag) og 2 patienter fik også infliximab.
English: • inflammation of the kidneys: symptoms may include decrease in the amount of urine you pass;
Danish: • nyrebetændelse: Symptomerne kan indebære et fald i mængden af urin
English: Immune-mediated pneumonitis
Danish: Immunmedieret pneumonitis
English: • inflammation of the heart muscle: symptoms may include chest pain, shortness of breath or irregular heartbeat;
Danish: • betændelse i hjertemusklen: Symptomerne kan omfatte brystsmerter, åndenød eller uregelmæssig hjerterytme
English: Talk to your doctor if you are not sure.
Danish: Spørg lægen, hvis der er noget, du er i tvivl om.
English: Grade 2 with ALT or AST > 3-5 x ULN and/or total bilirubin > 1.5-3 x ULN
Danish: Grad 2 med ALAT eller ASAT >3-5 x ULN og/eller total bilirubin >1,5-3 x ULN Tilbagehold dosis
English: Patients should be monitored for abnormal thyroid function tests prior to and periodically during treatment and as indicated based on clinical evaluation.
Danish: Patienter bør monitoreres for unormale thyroideafunktionsprøver før og periodisk under behandling og som indiceret på baggrund af klinisk vurdering.
English: Immune-mediated rash or dermatitis
Danish: Immunmedieret udslæt eller dermatitis
English: Do not shake the vial.
Danish: Ryst ikke hætteglasset.
English: The median time to onset was 41 days (range: 14-195 days).
Danish: Mediantiden til debut var 41 dage (interval: 14-195 dage).
English: IMFINZI was discontinued in 8 patients.
Danish: IMFINZI blev seponeret hos 8 patienter.
English: Immune-mediated myocarditis
Danish: Immunmedieret myokarditis
English: How you are given IMFINZI
Danish: Sådan vil du få IMFINZI
English: Immune-mediated type 1 diabetes mellitus occurred in patients receiving IMFINZI (see section 4.8).
Danish: Immunmedieret type 1-diabetes mellitus forekom hos patienter, der fik IMFINZI (se pkt.
English: • inflammation of the intestines: symptoms may include diarrhoea or more bowel movements than usual, or stools that are black, tarry or sticky with blood or mucus, severe stomach pain or tenderness;
Danish: • tarmbetændelse: Symptomerne kan omfatte diarré eller flere afføringer end normalt, eller afføring, der er sort, tjæreagtig eller klæbrig med blod eller slim, svære mavesmerter eller ømhed i maven
English: • inflammation of the lungs: symptoms may include new or worsening cough, shortness of breath or chest pain;
Danish: • betændelse i lungerne: Symptomerne kan omfatte ny eller forværret hoste, kortåndethed eller brystsmerter
English: Patients should be monitored for signs and symptoms of colitis or diarrhoea and managed as recommended in section 4.2.
Danish: Patienterne bør monitoreres for tegn og symptomer på colitis eller diarré og behandles som anbefalet i pkt.
English: Kaplan-Meier curve of OS for PD-L1 TC ≥ 1%
Danish: Figur 3: Kaplan-Meier-kurve over OS for PD-L1 TC ≥ 1 %
English: IMFINZI was not discontinued in any patient due to hyperthyroidism.
Danish: IMFINZI blev ikke seponeret hos nogen patienter på grund af hyperthyreoidisme.
English: Patients should be monitored for signs and symptoms and managed as recommended for other immune-mediated adverse reactions, in section 4.2.
Danish: Patienter skal monitoreres for tegn og symptomer og behandles som anbefalet for andre immunmedierede bivirkninger i pkt.
English: IMFINZI was not discontinued in any patient due to hypothyroidism.
Danish: IMFINZI blev ikke seponeret hos nogen patienter på grund af hypothyreoidisme.
English: In the combined safety database with IMFINZI monotherapy, immune-mediated hyperthyroidism occurred in 34 (1.8%) patients, there were no Grade 3 or 4 cases.
Danish: I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret hyperthyreoidisme hos 34 (1,8 %) patienter; der forekom ingen tilfælde af Grad 3 eller 4.
English: • tooth and mouth soft tissue infections
Danish: • infektioner i tandkød og mundvæv
English: The median time to onset was 53 days (range: 1-341 days).
Danish: Mediantiden til debut var 53 dage (interval: 1-341 dage).
English: IMFINZI is supplied as a single-dose vial and does not contain any preservatives, aseptic technique must be observed.
Danish: IMFINZI leveres i enkeltdosis hætteglas og indeholder ingen konserveringsmidler.
English: • inflammation of the skin: symptoms may include rash, itching, skin blistering or ulcers in the mouth or on other moist surfaces;
Danish: • betændelse i huden: Symptomerne kan omfatte udslæt, kløe, blærer på huden eller sår i munden eller på andre slimhinder
English: Each mL of concentrate for solution for infusion contains 50 mg of durvalumab.
Danish: Hver ml koncentrat til infusionsvæske, opløsning indeholder 50 mg durvalumab.
English: If any of the above apply to you (or you are not sure), talk to your doctor before you are given IMFINZI.
Danish: Hvis noget af ovenstående gælder for dig (eller du er i tvivl), skal du tale med din læge, før du får IMFINZI.
English: Grade 3 with serum creatinine > 3 x baseline or > 3-6 x ULN; Grade 4 with serum creatinine > 6 x ULN
Danish: Grad 3 med serumkreatinin >3 x baseline eller >3-6 x ULN;
English: includes abdominal pain, abdominal pain lower, abdominal pain upper and flank pain.
Danish: j omfatter abdominalsmerter, nedre abdominalsmerter, øvre abdominalsmerter og lændesmerter.
English: What IMFINZI looks like and contents of the pack IMFINZI concentrate for solution for infusion is a sterile, preservative-free, clear to opalescent, colourless to slightly yellow solution, free from visible particles.
Danish: IMFINZI koncentrat til infusionsvæske, opløsning er en steril, klar til opaliserende, farveløs til svagt gul opløsning uden konserveringsmidler, der er fri for synlige partikler.
English: Clear to opalescent, colourless to slightly yellow solution, free from visible particles.
Danish: Klar til opaliserende, farveløs til svagt gul opløsning, fri for synlige partikler.
English: The concentrate is a clear to opalescent, colourless to slightly yellow solution, free from visible particles.
Danish: Koncentratet er en klar til opaliserende, farveløs til svagt gul opløsning, der er fri for synlige partikler.
English: The median time to onset was 74 days (range: 1-365 days).
Danish: Mediantiden til debut var 74 dage (interval: 1-365 dage).
English: Hypophysitis/Hypopituitarism
Danish: Hypofysitis/hypopituitarisme
English: Hypophysitis/hypopituitarism
Danish: Hypofysitis/ Hypopituitarisme
English: In the PACIFIC Study, in patients who had completed treatment with at least 2 cycles of concurrent chemoradiation within 1 to 42 days prior to initiation of the trial, pneumonitis or radiation pneumonitis occurred in 161 (33.9%) patients in the IMFINZI-treated group and 58 (24.8%) in the placebo group, including Grade 3 (3.4% vs 3.0%) and Grade 5 (1.1% vs 1.7%) (see section 4.8).
Danish: Strålingspneumonitis observeres hyppigt hos patienter, der modtager strålebehandling af lungerne, og den kliniske præsentation af pneumonitis og strålingspneumonitis er meget ens. I PACIFIC-studiet forekom pneumonitis eller strålingspneumonitis hos patienter, der havde afsluttet behandling med mindst 2 behandlingscykler samtidig kemostråling inden for 1 til 42 dage før forsøgets begyndelse, hos 161 (33,9 %) patienter i den gruppe, der fik IMFINZI, og 58 (24,8 %) i placebogruppen, inklusive Grad 3 (3,4 % versus 3,0 %) og Grad 5 (1,1 % versus 1,7 %) (se pkt.
English: What IMFINZI contains The active substance is durvalumab.
Danish: IMFINZI indeholder: Aktivt stof: durvalumab
English: Immune-mediated hypothyroidism
Danish: Immunmedieret hypothyreoidisme
English: Immune-mediated hypophysitis or hypopituitarism occurred in patients receiving IMFINZI (see section 4.8).
Danish: Immunmedieret hypofysitis eller hypopituitarisme forekom hos patienter, der fik IMFINZI (se pkt.
English: One ml of concentrate contains 50 mg of durvalumab.
Danish: 1 ml koncentrat indeholder 50 mg durvalumab.
English: IMFINZI 50 mg/ml sterile concentrate durvalumab
Danish: IMFINZI 50 mg/ml sterilt koncentrat durvalumab i.v.
English: Immune-mediated endocrinopathies
Danish: Immunmedierede endokrinopatier
English: IMFINZI was discontinued in all 3 patients.
Danish: IMFINZI blev seponeret hos alle tre patienter.
English: Discard any unused portion left in the vial.
Danish: Kassér eventuelt ubrugt lægemiddel, som er tilbage i hætteglasset.
English: Two (0.1%) patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Danish: 2 (0,1 %) patienter fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag).
English: In the combined safety database with IMFINZI monotherapy, (n = 1889 multiple tumour types), immune-mediated pneumonitis occurred in 79 (4.2%) patients, including Grade 3 in 12 (0.6%) patients, Grade 4 in 1 (< 0.1%) patient, and Grade 5 in 5 (0.3%) patients.
Danish: I den kombinerede sikkerhedsdatabase med IMFINZI-monoterapi (n = 1889 multiple tumortyper) forekom der immunmedieret pneumonitis hos 79 (4,2 %) patienter, herunder Grad 3 hos 12 (0,6 %) patienter.
English: Immune-mediated pneumonitis or interstitial lung disease, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI.
Danish: Immunmedieret pneumonitis eller interstitiel lungesygdom, defineret som behandlingskrævende med systemiske kortikosteroider og uden klar alternativ ætiologi, forekom hos patienter, der fik IMFINZI.
English: Immune-mediated adrenal insufficiency occurred in patients receiving IMFINZI (see section 4.8).
Danish: Immunmedieret adrenal insufficiens forekom hos patienter, der fik IMFINZI (se pkt.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, monoklonale antistoffer, ATC-kode: L01XC28
English: Patients should be monitored for abnormal renal function tests prior to and periodically during treatment with IMFINZI and managed as recommended in section 4.2.
Danish: Patienterne bør monitores for unormale nyrefunktionsprøver før og periodisk under behandling med IMFINZI og behandles som anbefalet i pkt.
English: Other immune-mediated adverse reactions
Danish: Andre immunmedierede bivirkninger
English: MedImmune Pharma B.V. Lagelandseweg 78
Danish: MedImmune Pharma B.V.
English: IMFINZI was discontinued in 2 patients.
Danish: IMFINZI blev seponeret hos 2 patienter.
English: Immune-mediated hyperthyroidism
Danish: Immunmedieret hyperthyreoidisme
English: In the combined safety database with IMFINZI monotherapy, infusion related reactions occurred in 35 (1.9%) patients, including Grade 3 in 5 (0.3%) patients.
Danish: I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom infusionsrelaterede reaktioner hos 35 (1,9 %) patienter, inklusive Grad 3 hos 5 (0,3 %) patienter.
English: IMFINZI was discontinued in 4 patients.
Danish: IMFINZI blev seponeret hos 4 patienter.
English: • inflammation of the muscle
Danish: • muskelbetændelse
English: • overactive thyroid gland that can cause fast heart rate or weight loss
Danish: • øget funktion af skjoldbruskkirtlen, der kan forårsage hurtig hjerterytme eller vægttab
English: In the combined safety database with IMFINZI monotherapy, immune-mediated hepatitis occurred in 19 (1.0%) patients, including Grade 3 in 11 (0.6%) patients and Grade 5 (fatal) in 1 (< 0.1%) patient.
Danish: I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret hepatitis hos 19 (1,0 %) patienter, inklusive Grad 3 hos 11 (0,6 %) patienter og Grad 5 (letal) hos 1 (<0,1 %) patient.
English: One vial of 2.4 ml of concentrate contains 120 mg of durvalumab.
Danish: Et hætteglas med 2,4 ml koncentrat indeholder 120 mg durvalumab.
English: In the combined safety database with IMFINZI monotherapy, immune-mediated colitis or diarrhoea occurred in 31 (1.6%) patients, including Grade 3 in 6 (0.3%) patients and Grade 4 in 1 (<0.1%) patient.
Danish: I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret colitis eller diarré hos 31 (1,6 %) patienter, inklusive Grad 3 hos 6 (0,3 %) patienter og Grad 4 hos 1 (<0,1 %) patient.
English: Permanently discontinue a
Danish: Permanent seponering a
English: IMFINZI 50 mg/ml concentrate for solution for infusion durvalumab
Danish: IMFINZI 50 mg/ml koncentrat til infusionsvæske, opløsning durvalumab
English: What IMFINZI is and what it is used for What you need to know before you are given IMFINZI How you are given IMFINZI Possible side effects
Danish: Det skal du vide, før du begynder at få IMFINZI Sådan vil du få IMFINZI Bivirkninger
English: Patients should be monitored for signs and symptoms of rash or dermatitis and managed as recommended in section 4.2.
Danish: Patienterne bør monitoreres for tegn og symptomer på udslæt eller dermatit og behandles som anbefalet i pkt.
English: One vial of 10 mL of concentrate contains 500 mg of durvalumab.
Danish: Et hætteglas med 10 ml koncentrat indeholder 500 mg durvalumab.
English: Patient reported outcomes
Danish: Patientrapporterede resultater
English: Reproductive toxicology
Danish: Reproduktionstoksicitet.
English: In the combined safety database with IMFINZI monotherapy, immune-mediated rash or dermatitis occurred in 30 (1.6%) patients, including Grade 3 in 7 (0.4%) patients.
Danish: I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret udslæt eller dermatitis hos 30 (1,6 %) patienter, inklusive Grad 3 hos 7 (0,4 %) patienter).
English: In the combined safety database with IMFINZI monotherapy, immune-mediated type 1 diabetes mellitus occurred in 1 (< 0.1%) patient (Grade 3).
Danish: I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret type 1-diabetes mellitus hos 1 (< 0,1 %) patient (Grad 3).
English: In the combined safety database with IMFINZI monotherapy, immune-mediated hypothyroidism occurred in 137 (7.3%) patients, including Grade 3 in 1 (< 0.1%) patient.
Danish: I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret hypothyreoidisme hos 137 (7,3 %) patienter, inklusive Grad 3 hos 1 (< 0,1 %) patient.