natgillin/translations-raw huggingface dataset:
Grad 1 Hånd- og fodsyndrom defineres som følelsesløshed, dysæstesi/paræstesi, prikken, hævelse eller erytem uden smerter af hænderne og/eller fødderne og/eller ubehag der ikke påvirker patienternes daglige aktiviteter.
Grade 1 hand-foot syndrome is defined as numbness, dysesthesia/paresthesia, tingling, painless swelling or erythema of the hands and/or feet and/or discomfort which does not disrupt the patient’s normal activities.
Grad 1 og 2
Grades 1 and 2
Grad 1 og grad 2 diabetes mellitus og grad 4 diabetisk ketoacidose blev hver især rapporteret hos 0,2% (1/448) af patienterne.
Grade 1 and Grade 2 diabetes mellitus and Grade 4 diabetic ketoacidosis were each reported in 0.2% (1/448) of patients.
Grad 1-2
Grade 1-2
Grad 1-2 (let til moderat): Når patientens tilstand er stabil, kan infusionen genoptages ved en hastighed, der ikke må overstige halvdelen af den hastighed, ved hvilken IRR'en opstod.
Grade 1-2 (mild to moderate): Once the patient’s condition is stable, the infusion should be resumed at no more than half the rate at which the IRR occurred.
Grad 1-2 (mild til moderat): Infusionshastigheden skal reduceres og symptomerne behandles.
Grade 1-2 (mild to moderate): The infusion rate must be reduced and symptoms treated.
Grad 1-4 (%)
Grades 1-4 (%)
Grad 1: fortsæt langsom infusion under nøje overvågning
Grade 1: continue slow infusion under close supervision
Grad 2
0.79
Grad 2 (<75, ≥50x109/l)
Grade 2 (<75, ≥50x109/l)
Grad 2 (intolerabel) eller grad 3 /4
Grade 2 (intolerable) or Grade 3/4
Grad 2 (N=107)
Grade 2 (N=107)
Grad 2 (uacceptabel) eller grad 3
Grade 2 (intolerable) or Grade 3
Grad 2 (≥1x109/l)
Grade 2 (≥1x109/l)
Grad 2 (1,5 til ≤3  øvre normalgrænse)
Grade 2 ( 1.5 to ≤ 3  the ULN)
Grad 2 (2,5 til ≤5  øvre normalgrænse)
Grade 2 ( 2.5 to ≤ 5  the ULN)
Grad 2 eller 3 forhøjelse af kreatinin Dosis/doser udsættes, indtil kreatinin vender tilbage til baseline, og behandling med kortikosteroid er afsluttet
Grade 2 or 3 creatinine elevation Withhold dose(s) until creatinine returns to baseline and management with corticosteroids is complete
Grad 2 eller 3 forhøjelse af kreatinin Nivolumab BMS udsættes, indtil kreatinin vender tilbage til baseline, og behandling med kortikosteroid er afsluttet
Grade 2 or 3 creatinine elevation Withhold Nivolumab BMS until creatinine returns to baseline and management with corticosteroids is complete
Grad 2 eller 3 kutan toksicitet.
Grade 2 or 3 cutaneous toxicity
Grad 2 hånd- og fodsyndrom defineres som smertefuld erytem og hævelse af hænderne og/eller fødderne og/eller ubehag der påvirker patienternes daglige aktiviteter.
Grade 2 hand- foot syndrome is painful erythema and swelling of the hands and/or feet and/or discomfort affecting the patient’s activities of daily living.
Grad 2 hånd- og fodsyndrom defineres som smertefuld erytem og hævelse af hænderne og/eller fødderne og/eller ubehag der påvirker patienternes daglige aktiviteter.
Grade 2 hand-foot syndrome is painful erythema and swelling of the hands and/or feet and/or discomfort affecting the patient’s activities of daily living.
Grad 2 hånd- og fodsyndrom defineres som smertefuld erytem og hævelse af hænderne og/eller fødderne og/eller ubehag, der påvirker patienternes daglige aktiviteter.
Grade 2 hand-foot syndrome is painful erythema and swelling of the hands and/or feet and/or discomfort affecting the patient’s activities of daily living.
Grad 2 med aspartataminotransferase (ASAT) eller alaninaminotransferase (ALAT) > 3-5 gange ULN eller total- bilirubin > 1,5-3 gange ULN
Grade 2 with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 to 5 times ULN or total bilirubin > 1.5 to 3 times ULN
Grad 2 og grad 3 binyrebarkinsufficiens forekom hver især hos 1,1% (5/448), og grad 4 binyrebarkinsufficiens forekom hos 0,2% (1/448) af patienterne.
Grade 2 and Grade 3 adrenal insufficiency each occurred in 1.1% (5/448), and Grade 4 adrenal insufficiency occurred in 0.2% (1/448) of patients.
Grad 2 og grad 3 hypofysitis forekom hos henholdsvis 6,0% (27/448) og 1,8% (8/448) af patienterne.
Grade 2 and Grade 3 hypophysitis occurred in 6.0% (27/448) and 1.8% (8/448) of patients, respectively.
Grad 2 og grad 3 thyroidearelaterede bivirkninger blev rapporteret hos henholdsvis 13,4% (60/448) og 1,6% (7/448) af patienterne.
Grade 2 and Grade 3 thyroid disorders were reported in 13.4% (60/448) and 1.6% (7/448) of patients, respectively.
Grad 2 og grad 3 tilfælde blev rapporteret hos henholdsvis 19,2% (86/448) og 7,4% (33/448) af patienterne.
Grade 2 and Grade 3 cases were reported in 19.2% (86/448) and 7.4% (33/448) of patients, respectively.
Grad 2 pancreatitis og/eller asymptomatisk forhøjelse af lipase/amylase
Grade 2 pancreatitis and/or asymptomatic elevation of lipase/amylase
Grad 2 pneumonitis Dosis/doser udsættes, indtil symptomerne forsvinder, radiografiske
Grade 2 pneumonitis Withhold dose(s) until symptoms resolve, radiographic abnormalities improve, and management with corticosteroids is complete
Grad 2 pneumonitis Nivolumab BMS udsættes, indtil symptomer forsvinder, radiografiske
Grade 2 pneumonitis Withhold Nivolumab BMS until
Grad 2 tilfælde blev rapporteret hos 2,2% (10/448) af patienterne.
Grade 2 cases were reported in 2.2% (10/448) of patients.
Grad 2 uden nedsat nyrefunktion (serum-Cr ≤ ULN)
Grade 2 without renal impairment (serum Cr ≤ ULN)
Grad 2, 3 bradykardic, d
Grade 2, 3 Bradycardiac,d
Grad 2, 3 eller 4 ALAT- eller ASAT-stigning med samtidig grad 2, 3 eller 4 total bilirubin- stigning (uden kolestase eller hæmolyse)
Grade 2, 3 or 4 ALT or AST elevation with concurrent Grade 2, 3 or 4 total bilirubin elevation (in the absence of cholestasis or haemolysis)
Grad 2, grad 3 og grad 4 tilfælde blev rapporteret hos henholdsvis 1,1% (5/448), 0,9% (4/448) og 0,7% (3/448) af patienterne.
Grade 2, Grade 3, and Grade 4 cases were reported in 1.1% (5/448), 0.9% (4/448), and 0.7% (3/448) of patients, respectively.
Grad 2, grad 3 og grad 4 tilfælde blev rapporteret hos henholdsvis 13,2% (59/448), 15,4% (69/448) og 0,4% (2/448) af patienterne.
Grade 2, Grade 3, and Grade 4 cases were reported in 13.2% (59/448), 15.4% (69/448), and 0.4% (2/448) of patients, respectively.
Grad 2, grad 3 og grad 4 tilfælde blev rapporteret hos henholdsvis 4,5% (20/448), 1,1% (5/448) og 0,2% (1/448) af patienterne.
Grade 2, Grade 3, and Grade 4 cases were reported in 4.5% (20/448), 1.1% (5/448), and 0.2% (1/448) of patients, respectively.
Grad 2, grad 3 og grad 4 tilfælde blev rapporteret hos henholdsvis 6,3% (28/448), 15,0% (67/448) og 1,8% (8/448) af patienterne.
Grade 2, Grade 3, and Grade 4 cases were reported in 6.3% (28/448), 15.0% (67/448), and 1.8% (8/448) of patients, respectively.
Grad 2: fortsæt langsom infusion og behandl omgående symptomer
Grade 2: continue slow infusion and immediately administer treatment for symptoms
Grad 2b,c
Grade 2b,c
Grad 3 & 4 (<50x109/l)
Grade 3 & 4 (<50x109/l)
Grad 3 & 4 n (%)
Grade 3 & 4 n (%)
Grad 3 (%)
Grade 3 (%)
Grad 3 (<1, ≥0,5x109/l)
Grade 3 (<1, ≥0.5x109/l)
Grad 3 (første forekomst) Dosis/doser udsættes
Grade 3 (first occurrence) Withhold dose(s)
Grad 3 (smertefuld erytem, ødem eller sår, men kan ikke spise)
Grade 3 (painful erythema, edema, or ulcers, but cannot eat)
Grad 3 (svær)
Grade 3 (severe)
Grad 3 (svær): Hvis intensiteten af IRR'en reduceres til grad 2 eller lavere, kan det overvejes at genstarte infusionen ved en hastighed, der ikke må overstige halvdelen af den hastighed, ved hvilken IRR'en opstod.
Grade 3 (severe): If the intensity of the IRR decreases to Grade 2 or lower, restarting of the infusion may be considered at no more than half the rate at which the reaction occurred.
Grad 3 (svær): Infusionen skal midlertidigt afbrydes og symptomerne behandles.
Grade 3 (severe): Infusion must be temporarily stopped and symptoms treated.
Grad 3 (3 til ≤10  øvre normalgrænse)
Grade 3 ( 3 to ≤ 10  the ULN)
Grad 3 (5 til ≤20  øvre normalgrænse)
Grade 3 ( 5 to ≤ 20  the ULN)
Grad 3 diarre eller colitis
Grade 3 diarrhoea or colitis
Grad 3 diarré
Grade 3 diarrhoea
Grad 3 eller 4 alanin-aminotransferase (ALAT)- eller aspartat-aminotransferase (ASAT)-stigning med grad ≤ 1 total bilirubin
Grade 3 or 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation with Grade ≤1 total bilirubin
Grad 3 eller 4 binyrebarkinsufficiens
Grade 3 or 4 adrenal insufficiency
Grad 3 eller 4 diarre eller colitis
Grade 3 or 4 diarrhoea or colitis
Grad 3 eller 4 eller tilbagevendende grad 2
Grade 3 or 4, or recurrent Grade 2
Grad 3 eller 4 febrile episoder med neutropeni blev observeret (2,2 % af lenalidomidbehandlede patienter, sammenlignet med 0,0 % hos patienter på placebo).
Grade 3 or 4 febrile neutropenia episodes were observed in 2.2% of lenalidomide-treated patients compared with 0.0% in patients on placebo).
Grad 3 eller 4 febrile episoder med neutropeni blev observeret hos 6,0 % i lenalidomidarmen sammenlignet med 2,4 % i kontrolarmen.
Grade 3 or 4 febrile neutropenia episodes were observed in 6.0% of lenalidomide-treated patients compared with 2.4% in patients on control arm.
Grad 3 eller 4 febrile episoder med neutropeni blev observeret hos 6,0 % i lenalidomidarmen, sammenlignet med 2,4 % i kontrolarmen.
Grade 3 or 4 febrile neutropenia episodes were observed in 6.0% of lenalidomide-treated patients compared with 2.4% in patients on control arm.
Grad 3 eller 4 ikke-hæmatologiske toksiciteter.
Grade 3 or 4 non-hematological toxicities.
grad 3 eller 4 laboratorietestabnormitet, følgende: 13,2% for nedsat lymfocyttal, 9% for hyponatriæmi, 2,9% for hyperkalciæmi og hyperkaliæmi, 2,5% for nedsat hæmoglobin (alle grad 3), 2,0% for hypokaliæmi, 1,6% for nedsat neutrofiltal, 1,3% for hypomagnesiæmi, 1,2% for hypokalcæmi, 0,8% for forhøjet total-bilirubin og 0,4% for forhøjet ASAT, nedsat trombocyttal, hypermagnesiæmi og hypernatriæmi.
In CA209017 and CA209063, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 13.2% for decreased lymphocytes, 9% for hyponatraemia, 2.9% for hypercalcaemia and hyperkalaemia, 2.5% for decreased haemoglobin (all Grade 3), 2.0% for hypokalaemia, 1.6% for decreased neutrophil count, 1.3% for hypomagnesaemia, 1.2% for hypocalcaemia, 0.8% for increased total bilirubin, and 0.4% for increased AST, decreased platelet, hypermagnesaemia, and hypernatraemia.
Grad 3 eller 4 non- hæmatologisk medicinrelateret toksicitet
Grade 3 or 4 non-hematologic medicine related toxicity
Grad 3 eller 4 pneumonitis Behandlingen seponeres permanent
Grade 3 or 4 pneumonitis Permanently discontinue treatment
Grad 3 eller 4 reaktioner forekom hos 1,0 % af patienterne, som fik Pom + LD-Dex, og hos 1,3 % af patienterne, som fik HD-Dex.
Grade 3 or 4 reactions occurred in 1.0 % of patients who received Pom + LD-Dex and in 1.3% of patients who received HD-Dex.
Grad 3 eller 4 reaktioner forekom hos 1,3 % af patienterne, som fik Pom + LD-Dex, og ikke hos nogen patienter, som fik HD-Dex.
Grade 3 or 4 reactions occurred in 1.3 % of patients who received Pom + LD-Dex, and no patients who received HD-Dex.
Grad 3 eller 4 tilfælde indberettedes hos 0,4% af patienterne.
Grade 3 or 4 events were reported in 0.4% of patients.
Grad 3 eller 4 uden nedsat nyrefunktion (serum-Cr ≤ ULN)
Grade 3 or 4 without renal impairment (serum Cr ≤ ULN)
Grad 3 eller højerec
Grade 3 or higherc
Grad 3 GI-fisteldannelse forekom hos 2 patienter, som blev behandlet med ZALTRAP (0,3 %), og hos en patient, som blev behandlet med placebo (0,2 %).
Grade 3 GI fistula formation occurred in 2 patients treated with ZALTRAP (0.3%) and in 1 placebo-treated patient (0.2%).
Grad 3 hypertension (der krævede justering af eksisterende antihypertensiv behandling eller behandling med mere end et lægemiddel) blev indberettet hos 1,5 % af patienterne i placeboarmen og hos 19,1 % i ZALTRAP-armen.
Grade 3 hypertension (requiring adjustment in existing anti-hypertensive therapy or treatment with more than one medicinal product) was reported in 1.5% of patients treated with the placebo/FOLFIRI regimen and 19.1% of patients treated with the ZALTRAP/FOLFIRI regimen.
Grad 3 mukosit
Grade 3 mucositis
Grad 3 og 4 neutropeni sås hos henholdsvis 7,5% og 2,7% af patienterne og grad 3 trombocytopeni hos 0,7% af patienterne.
Grade3 and 4 neutropenia was seen in 7.5% and 2.7% of patients, respectively, and grade3 thrombocytopenia in 0.7% of patients.
Grad 3 og 4 tilfælde blev rapporteret hos henholdsvis 0,8% (14/1.728) og <0,1% (1/1.728) af patienterne.
Grade 3 and 4 cases were reported in 0.8% (14/1728) and <0.1% (1/1728) of patients respectively.
Grad 3 og 4 tilfælde blev rapporteret hos henholdsvis 1,4% (25/1.728) og 0,3% (6/1.728) af patienterne.
Grade 3 and 4 cases were reported in 1.4% (25/1728) and 0.3% (6/1728) of patients, respectively.
Grad 3 og 4*
Grades 3 and 4
Grad 3 opkastning som  6 episoder i løbet af 24 timer efter præmedikation eller behov for i.v.-væskebehandling.
Grade 3 vomiting as  6 episodes in 24 hours over pretreatment; or need for intravenous fluids.
Grad 3 reaktioner forekom hos 10,7 % af de lenvatinibbehandlede patienter, og ikke hos nogen af de placebobehandlede patienter.
Grade 3 reactions occurred in 10.7% of lenvatinib-treated patients and none in placebo- treated patients.
Grad 3 thyroidearelaterede bivirkninger blev rapporteret hos 0,1% (2/1.728) af patienterne.
Grade 3 thyroid disorders were reported in 0.1% (2/1728) of patients.
Grad 3 tilfælde blev rapporteret hos 1,6% (27/1.728) af patienterne.
Grade 3 cases were reported in 1.6% (27/1728) of patients.
grad 3 tilfælde, fik højdosis kortikosteroid (i en dosis mindst ækvivalent med 40 mg prednison) med en median initialdosis på 0,6 mg/kg (0,4-1,3) i en medianperiode på 2,0 uger (1,4-14,1).
Three patients, including 2 patients with a Grade 3 case, received high-dose corticosteroids (at least 40 mg prednisone equivalents) at a median initial dose of 0.6 mg/kg (range: 0.4-1.3) for a median duration of 2.0 weeks (range: 1.4-14.1).
Grad 3 træthed (dosisbegrænsende toksicitet) og grad 3 hypertension blev hver for sig set hos 1 ud af 3 patienter, som fik henholdsvis 2000 mg og 1000 mg dagligt.
Grade 3 fatigue (dose limiting toxicity) and Grade 3 hypertension were each observed in 1 of 3 patients dosed at 2000 mg and 1000 mg daily, respectively.
Grad 3 udslæt Dosis/doser udsættes, indtil symptomerne forsvinder, og behandling med kortikosteroid er afsluttet
Grade 3 rash Withhold dose(s) until symptoms resolve and management with corticosteroids is complete
Grad 3*
Grade 3
Grad 3- eller 4-reaktioner ved infusion er ikke- almindeligt forekommende efter den første behandlingsuge.
Grade 3 or 4 infusion reactions are uncommon after the first week of therapy.
Grad 3-4 blødning inklusive GI-blødning, hæmaturi og postoperativ blødning blev indberettet hos 2,9 % af patienterne i ZALTRAP-armen og hos 1,7 % i placeboarmen.
Grade 3-4 haemorrhage including GI haemorrhage, haematuria, and post-procedural haemorrhage was reported in 2.9% of patients receiving the ZALTRAP/FOLFIRI regimen compared with 1.7% of patients receiving the placebo/FOLFIRI regimen.
Grad 3-4 GI-perforation forekom hos alle 3 patienter (0,5 %) i ZALTRAP-armen, og hos 2 patienter (0,3 %) i placeboarmen.
Grade 3-4 GI perforation events occurred in all 3 patients (0.5%) treated with the ZALTRAP/FOLFIRI regimen and in 2 patients (0.3%) treated with the placebo/FOLFIRI regimen.
Grad 3-4 toksicite t (%)
Grade 3-4 toxicity (%)
Grad 3-4-bivirkninger/ hyppighed
Grade 3−4 ADRs/Frequency
Grad 3-4a (%)
Grades 3-4a (%)
Grad 3-5†
Grades 3-5
Grad 3/4 (%)
Grade 3
Grad 3/4 (%)
Grade 3 - 4 toxicity (%)
Grad 3/4 (%)
Grade 3 – 4 toxicity (%)
Grad 3/4 (%)
Grade 3/4 toxicity (%)
Grad 3/4 hyppighed
Grade 3/4 frequency
Grad 3/4 ileus, rapporteret hos 1,8% af patienterne, var reversibel, når det blev behandlet medicinsk.
Grade 3/4 ileus reported in 1.9% of patients was reversible when managed by medical care.
Grad 3/4 neutropeni blev observeret hos 50,2% af patienterne.
Grade 3/4 neutropenia was observed in 43.8% of patients.
Grad 3/4** n=318 ( 5 % )
Grades 3/4** n=318 ( 5%)
Grad 4 (%)
Grade 4 (%)
Grad 4 (<0,5x109/l)
Grade 4 (<0.5x109/l)
Grad 4 (livstruende)
Grade 4 (life-threatening)
Grad 4 (livstruende) - < 120 mmol/l trods korrekt håndtering af væske
Grade 4(life-threatening) - < 120 mmol/L despite appropriate fluid management
Grad 4 (livstruende): Behandling med DARZALEX seponeres permanent.
Grade 4 (life-threatening): Permanently discontinue DARZALEX treatment.
Grad 4 (livstruende): Infusionen skal afbrydes og behandlingen permanent seponeres.
Grade 4 (life threatening): Infusion must be stopped and therapy must be permanently discontinued.
Grad 4 (Trombocyttal 25.000/mm3)
Grade 4 (Platelets:  25,000/mm3)
Grad 4 (10  øvre normalgrænse)
Grade 4 ( 10  the ULN)
Grad 4 (20  øvre normalgrænse)
Grade 4 ( 20  the ULN)
Grad 4 bradykardic,d,e
Grade 4 Bradycardiac,d,e
Grad 4 diabetes
Grade 4 diabetes
Grad 4 diarre eller colitis Behandlingen seponeres permanent
Grade 4 diarrhoea or colitis Permanently discontinue treatment
Grad 4 diarre eller colitis Nivolumab BMS seponeres permanent
Grade 4 diarrhoea or colitis Permanently discontinue Nivolumab BMS
Grad 4 eller recidiverende grad 3; vedvarende grad 2 eller 3 på trods af behandlingsmodifikation; ikke muligt at reducere kortikosteroiddosis til 10 mg prednison dagligt eller en dosis
Grade 4 or recurrent Grade 3 ; persistent Grade 2 or 3 despite treatment modification ; inability to reduce corticosteroid dose to 10 mg prednisone or equivalent per day
Grad 4 febril neutropeni blev ikke observeret hyppigt (0,6 % sammenlignet med 0,7 % med MPT).
Grade 4 febrile neutropenia was observed infrequently (0.6% compared with 0.7% in MPT).
Grad 4 forhøjelse af kreatinin Behandlingen seponeres permanent
Grade 4 creatinine elevation Permanently discontinue treatment
Grad 4 forhøjelse af kreatinin Nivolumab BMS seponeres permanent
Grade 4 creatinine elevation Permanently discontinue Nivolumab BMS
Grad 4 hypertension (hypertensiv krise) blev indberettet hos 1 patient (0,2 %) i ZALTRAP-armen.
Grade 4 hypertension (hypertensive crisis) was reported in 1 patient (0.2%) treated with the ZALTRAP/FOLFIRI regimen.
Grad 4 hypertyroidisme
Grade 4 hyperthyroidism
Grad 4 hypofysitis
Grade 4 hypophysitis
Grad 4 hypotyroidisme
Grade 4 hypothyroidism
Grad 4 neutropeni (< 500 celler/mm3) forekom hos 9 % af de patienter, der blev behandlet med Abraxane.
Grade 4 neutropenia (< 500 cells/mm3) occurred in 9% of patients treated with Abraxane.
Grad 4 Seponér BLINCYTO permanent.
Discontinue BLINCYTO permanently.
Grad 4 udslæt Behandlingen seponeres permanent
Grade 4 rash Permanently discontinue treatment
Grad 4 venøs tromboemboli (inklusive lungeemboli)
Grade 4 venous thromboembolic events (including pulmonary embolism)
Grad 4(%)
Grade 4 (%)
Grad 4*
Grade 4
Grad af abnormitet
Degree of abnormality
Grad af blødning/type kirurgisk indgreb
Degree of haemorrhage / Type of surgical procedure
Grad af hudtoksicitet
Skin toxicity grade
Grad af lever- svækkelse*
Grade of hepatic impairment
Grad af leverfibrose
Extent of liver fibrosis
Grad af leverfunktions- nedsættelse*
Grade of hepatic impairment
Grad af leverfunktionsnedsættelse*
Grade of hepatic impairment
Grad af toksiciteta
Toxicity gradesa
Grad CTCa
CTC Grade
Grad ≥ 3 (%)
Grade ≥ 3 (%)
Grad ≥ 3 ikke- hæmatologisk toksicitet, som anses for relateret til VELCADE
Grade ≥ 3 non-haematological toxicities considered to be related to VELCADE
Grad ≥ 3 med kreatinin > 3 gange ULN
Grade ≥ 3 with creatinine > 3 times ULN
Grad1 (SE) af forværring i 52 uger
Rate1 (SE) of decline over 52 weeks
Grad>3 n (%)
Oropharyngeal pain
Gradb 3
Grade 3b
Gradc 3 (50.000- 25.000/mm3)
CTCAEc grade 3 (50,000 – 25,000/mm3)
Gradc 3 (<1.000-500/mm3)
CTCAEc grade 3 (<1,000 – 500/mm3)
Gradc 3 (<8,0-6,5g/dl)
CTCAEc grade 3 (<8.0 – 6.5g/dl)
Gradc 3 (>5-20 x ULN)
CTCAEc grade 3 (> 5x – 20 x ULN)
Gradc 4 (<25.000/mm3)
CTCAEc grade 4 (<25,000/mm3)
Gradc 4 (<500/mm3)
CTCAEc grade 4 (<500/mm3)
Gradc 4 (<6,5g/dl)
CTCAEc grade 4 (<6.5g/dl)
Graden af beskyttelse efter vaccination mod alvorlige typer rotavirus (RV)-gastroenteritis krævende hospitalisering og/eller medicinsk behandling af dehydrering versus genotype-specifik effektivitet af vaccinen efter 2 doser Rotarix er angivet i tabellen nedenfor.
The protective vaccine efficacy against severe rotavirus (RV) gastro-enteritis requiring hospitalisation and/or rehydration therapy in a medical facility and the genotype specific vaccine efficacy after two doses of Rotarix are presented in the table below:
Graden af effekt på andre arter kan være forskellig fra, hvad der er observeret hos kyllinger.
The level of efficacy for other species may differ from that observed in chickens.
Graden af interaktion med potente OATP-hæmmere (f.eks. visser statiner, proteinasehæmmere, tuberkulostatika) er ukendt.
The extent of interaction with potent OATP inhibitors (e.g. some statins, proteinase inhibitors, tuberculostatics) is unknown.
Graden af nedsat nyrefunktion blev defineret i henhold til kreatininclearance (CrCL) ved baselinie (normal nyrefunktion med CrCL > 80 ml/min; let nedsat nyrefunktion med CrCL = 50-79 ml/min; moderat nedsat nyrefunktion med CrCL = 30-49 ml/min og svært nedsat nyrefunktion med CrCL = 10-29 ml/min).
The degree of renal impairment was defined according to baseline creatinine clearance (CrCL) (normal renal function when CrCL > 80 mL/min; mild impairment with CrCL = 50-79 mL/min; moderate impairment with CrCL = 30-49 mL/min and severe impairment with CrCL = 10-29 mL/min).
Graden af nedsat nyrefunktion blev defineret i henhold til kreatininclearance (CrCl) ved baselinie (normal nyrefunktion med CrCl > 80 mL/min; let nedsat nyrefunktion med CrCl = 50−79 mL/min; moderat nedsat nyrefunktion med CrCl = 30−49 mL/min og svært nedsat nyrefunktion med CrCl = 10−29 mL/min).
The degree of renal impairment was defined according to baseline creatinine clearance (CrCl) (normal renal function when CrCl > 80 mL/min; mild impairment with CrCl = 50-79 mL/min; moderate impairment with CrCl = 30-49 mL/min and severe impairment with CrCl = 10-29 mL/min).
Graden af plasma proteinbinding for 99mTc-depreotid er cirka 12% hos patienter og raske frivillige.
99mTc-depreotide binds to the extent of about 12% to plasma proteins in patients and healthy volunteers.
Graden af reduktion er sandsynligvis klinisk signifikant (se pkt.4.5).
The degree of reduction is likely to be clinically significant (see section 4.5).
Graden af respons og bedring var også højere med Duloxetin Lilly sammenlignet med placebo.
Response and remission rates were also higher with Duloxetine Lilly compared to placebo.
Graden af svimmelhed, søvnighed og nedsat koncentrationsevne kan øges, når Pregabalin Accord tages sammen med medicin, der indeholder:
The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Accord is taken together with medicinal products containing:
Graden af svimmelhed, søvnighed og nedsat koncentrationsevne kan øges, når Pregabalin Sandoz GmbH tages sammen med medicin, der indeholder:
The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Sandoz GmbH is taken together with medicinal products containing:
Graden af svimmelhed, søvnighed og nedsat koncentrationsevne kan øges, når Pregabalin Sandoz tages sammen med medicin, der indeholder:
The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Sandoz is taken together with medicinal products containing:
Graden af svimmelhed, søvnighed og nedsat koncentrationsevne kan øges, når Pregabalin Zentiva tages sammen med medicin, der indeholder:
The degree of dizziness, sleepiness and decreased concentration may be increased if pregabalin is taken together with medicinal products containing:
Graden af variation mellem de enkelte patienter og mellem laboratorieanalyser af CD34+-celler vanskeliggør en direkte sammenligning af forskellige forsøg.
The degree of variation between individual patients and between laboratory assays of CD34+ cells mean that direct comparison between different studies is difficult.