natgillin/translations-raw huggingface dataset:
Der blev udført en eksploratorisk subgruppeanalyse i KEYNOTE-048 hos patienter, hvis tumorer udtrykte PD-L1 CPS ≥ 1 til < 20 [pembrolizumab plus kemoterapi: n=116 (45%) versus standardbehandling: n=125 (49%) og pembrolizumab som monoterapi: n=124 (48%) versus standardbehandling: n=133 (52%)] (se tabel 26). 
An exploratory subgroup analysis was performed in KEYNOTE-048 in patients whose tumours expressed PD-L1 CPS ≥ 1 to < 20 [pembrolizumab plus chemotherapy: n=116 (45%) vs. standard treatment: n=125 (49%) and pembrolizumab monotherapy: n=124 (48%) vs. standard treatment: n=133 (52%)] (see Table 26).
Hypertyroidisme medførte seponering af pembrolizumab hos 3 (0,1%) patienter. 
Hyperthyroidism led to discontinuation of pembrolizumab in 3 (0.1%) patients.
Antal hændelser (%) Median i måneder (95% CI) HR* (95% CI) p-værdi 
Number of events (%) Median in months (95% CI) Hazard ratio* (95% CI) p-Value
vitiligo (depigmentering af huden, hypopigmentering af huden og hypopigmentering af øjenlåget) u. likenoid keratose (lichen planus og lichen sclerosus) v. muskuloskeletale smerter (muskuloskeletale gener, rygsmerter, muskuloskeletal stivhed, muskuloskeletale brystsmerter og torticollis) w. myositis (myalgi, myopati, polymyalgia rheumatica og rabdomyolyse) x. artritis (hævede led, polyartritis og ledeffusion) y. tenosynovitis (tendinitis, synovitis og senesmerter) z. nefritis (autoimmun nefritis, tubulointerstitiel nefritis og nyresvigt, akut nyresvigt eller akut nyreskade med tegn på nefritis, nefrotisk syndrom) aa. ødem (perifert ødem, generaliseret ødem, overhydrering, væskeretention, øjenlågsødem og læbeødem, ansigtsødem, lokaliseret ødem og periorbitalt ødem) 
musculoskeletal pain (musculoskeletal discomfort, back pain, musculoskeletal stiffness, musculoskeletal chest pain and torticollis) w. myositis (myalgia, myopathy, polymyalgia rheumatica and rhabdomyolysis) x. arthritis (joint swelling, polyarthritis and joint effusion) y. tenosynovitis (tendonitis, synovitis and tendon pain) z. nephritis (nephritis autoimmune, tubulointerstitial nephritis and renal failure, renal failure acute, or acute kidney injury with evidence of nephritis, nephrotic syndrome) aa. oedema (oedema peripheral, generalised oedema, fluid overload, fluid retention, eyelid oedema and lip oedema, face oedema, localised oedema and periorbital oedema)
Et hætteglas med 4 ml indeholder 100 mg pembrolizumab. 
One vial of 4 mL contains 100 mg of pembrolizumab.
Patienterne blev randomiseret (1:1) til at få KEYTRUDA 200 mg hver 3. uge (n=270) eller investigators valg af en hvilken som helst af følgende kemoterapi-regimer, der alle gives intravenøst hver 3. uge (n=272): paclitaxel 175 mg/m2 (n=84), docetaxel 75 mg/m2 (n=84) eller vinflunin 320 mg/m2 (n=87). 
Patients were randomised (1:1) to receive either KEYTRUDA 200 mg every 3 weeks (n=270) or investigator's choice of any of the following chemotherapy regimens all given intravenously every 3 weeks (n=272): paclitaxel 175 mg/m
Figur 13: Kaplan-Meier-kurve for samlet overlevelse for pembrolizumab plus kemoterapi i KEYNOTE-048 med PD-L1-ekspression (CPS ≥ 1) 
Figure 13: Kaplan-Meier curve for overall survival for pembrolizumab plus chemotherapy in KEYNOTE-048 with PD-L1 expression (CPS ≥ 1)
Behandlingsarm OS-rate i måned 24 OS-rate i måned 36 HR (95% CI) 
Treatment arm OS rate at 24 months OS rate at 36 months HR (95% CI)
Virkningsstudie efter tilladelse til markedsføring (PAES): Indehaveren af markedsføringstilladelsen skal sørge for studierapporten for studie P361: Et randomiseret kontrolleret klinisk fase III-studie af pembrolizumab med eller uden platinbaseret kombineret kemoterapi versus kemoterapi hos forsøgspersoner med fremskredent eller metastatisk urotelialt karcinom - Studierapport 
Post-authorisation efficacy study (PAES): The MAH should provide the study report for study P361: A Phase III Randomised, Controlled Clinical Trial of Pembrolizumab with or without Platinum-Based Combination Chemotherapy versus Chemotherapy in Subjects with Advanced or Metastatic Urothelial Carcinoma - Study Report
Figur 15: Kaplan-Meier-kurve for samlet overlevelse for hver behandlingsarm hos patienter med PD-L1-ekspression (TPS ≥ 50%) i KEYNOTE-040 
Figure 15: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-040 patients with PD-L1 expression (TPS ≥ 50%)
KEYTRUDA 50 mg pulver til koncentrat til infusionsvæske, opløsning. 
KEYTRUDA 50 mg powder for concentrate for solution for infusion.
Hos patienterne i KEYNOTE-087 var baseline-karakteristika: medianalder 35 år (9% ≥ 65 år); 54% mænd; 88% kaukasere; og henholdsvis 49% og 51% havde ECOG-performance-status 0 og 1. 
Among KEYNOTE-087 patients, the baseline characteristics were median age 35 years (9% age 65 or older); 54% male; 88% White; and 49% and 51% had an ECOG performance status 0 and 1, respectively.
Vurdering af tumorstatus blev foretaget i uge 9, herefter hver 6. uge til og med uge 52, og efterfølgende hver 9. uge til og med måned 24. 
Assessment of tumour status was performed at 9 weeks, then every 6 weeks through week 52, followed by every 9 weeks through 24 months.
Behandlingen med pembrolizumab skal seponeres permanent ved en hvilken som helst immunrelateret bivirkning af grad 3, som recidiverer, og ved alle immunrelaterede bivirkninger af grad 4 (se pkt. 
Pembrolizumab must be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for any Grade 4 immune-related adverse reaction (see sections 4.2 and 4.8).
Et hætteglas med 4 ml koncentrat indeholder 100 mg pembrolizumab. 
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab.
§% (95% CI) Komplet respons Partielt respons p-værdi Responsvarighed Median i måneder (interval) 
§% (95% CI) Complete response Partial response p-Value Response duration Median in months (range)
Patienter med autoimmun sygdom, der havde krævet systemisk behandling inden for de seneste 2 år; lidelser, som krævede behandling med immunsuppressiva; eller patienter, som havde fået mere end 30 Gy torakal strålebehandling inden for de forudgående 26 uger, blev ekskluderet fra studiet. 
Patients with autoimmune disease that required systemic therapy within 2 years of treatment; a medical condition that required immunosuppression; or who had received more than 30 Gy of thoracic radiation within the prior 26 weeks were ineligible.
Virkningsstudie efter tilladelse til markedsføring (PAES): Indehaveren af markedsføringstilladelsen skal indsende den endelige studierapport for studie P204: Et randomiseret, åbent klinisk fase III-studie, der sammenligner pembrolizumab med brentuximab vedotin hos forsøgspersoner med recidiverende eller refraktært klassisk Hodgkins lymfom - Endelig studierapport 
Post-authorisation efficacy study (PAES): The MAH should submit the final study report for study P204: A Phase III, Randomised, Open-label, Clinical Trial to Compare Pembrolizumab with Brentuximab Vedotin in Subjects with Relapsed or Refractory Classical Hodgkin Lymphoma - Final Study Report
Figur 14: Kaplan-Meier-kurve for samlet overlevelse for pembrolizumab som monoterapi i KEYNOTE-048 med PD-L1-ekspression (CPS ≥ 1) 
Figure 14: Kaplan-Meier curve for overall survival for pembrolizumab as monotherapy in KEYNOTE-048 with PD-L1 expression (CPS ≥ 1)
Virkningsstudie efter tilladelse til markedsføring (PAES): Indehaveren af markedsføringstilladelsen skal indsende den endelige studierapport for studie P087: Et klinisk fase II-studie af MK-3475 (pembrolizumab) hos forsøgspersoner med recidiverende eller refraktært (R/R) klassisk Hodgkins lymfom (cHL) - Endelig studierapport 
Post-authorisation efficacy study (PAES): The MAH should submit the final study report for study P087, A Phase II Clinical Trial of MK-3475 (Pembrolizumab) in Subjects with Relapsed or Refractory (R/R) Classical Hodgkin Lymphoma (cHL) - Final Study Report
KEYTRUDA som monoterapi er indiceret til behandling af lokalt fremskredent eller metastatisk NSCLC hos voksne efter tidligere behandling med minimum én kemoterapi, og hvis tumorer udtrykker PD-L1 med TPS ≥ 1%. 
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen.
Hypofysitis forekom hos 36 (0,6%) patienter, som fik pembrolizumab, inklusive tilfælde af grad 2, 3 eller 4 hos henholdsvis 13 (0,2%), 19 (0,3%) og 1 (< 0,1%) patienter. 
Hypophysitis occurred in 36 (0.6%) patients, including Grade 2, 3 or 4 cases in 13 (0.2%), 19 (0.3%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab.
Kortikosteroider skal administreres (initialdosis 0,5-1 mg/kg/dag [ved bivirkninger af grad 2] eller 1-2 mg/kg/dag [ved bivirkninger ≥ grad 3] prednison eller ækvivalent hermed efterfulgt af langsom udtrapning), og på basis af sværhedsgraden af leverenzymstigningen skal behandlingen med pembrolizumab pauseres eller seponeres (se pkt. 
Corticosteroids should be administered (initial dose of 0.5-1 mg/kg/day (for Grade 2 events) and 1-2 mg/kg/day (for Grade ≥ 3 events) prednisone or equivalent followed by a taper) and, based on severity of liver enzyme elevations, pembrolizumab should be withheld or discontinued (see section 4.2).
HR* for PFS (95% CI) HR* for OS (95% CI) ORR % 
PFS Hazard ratio* (95% CI) OS Hazard ratio* (95% CI) ORR %
KEYTRUDA er ikke undersøgt hos patienter med moderat eller svært nedsat leverfunktion (se pkt. 
KEYTRUDA has not been studied in patients with moderate or severe hepatic impairment (see sections 4.4 and 5.2).
• KEYTRUDA 200 mg hver 3. uge, carboplatin AUC 5 mg/ml/min hver 3. uge eller cisplatin 
• KEYTRUDA 200 mg every 3 weeks, carboplatin AUC 5 mg/mL/min every 3 weeks or cisplatin 100 mg/m2 every 3 weeks, and 5-FU 1,000 mg/m2/d 4 days continuous every
‡ % (95% CI) Komplet respons % Partielt respons % p-værdi Responsvarighed Median i måneder (interval) 
‡ % (95% CI) Complete response % Partial response % p-Value Response duration Median in months (range)
Nefritis medførte seponering af pembrolizumab hos 10 (0,2%) patienter. 
Nephritis led to discontinuation of pembrolizumab in 10 (0.2%) patients.
5 mg/ml/min hver 3. uge eller cisplatin 100 mg/m 2 hver 3. uge, og 5-FU 1.000 mg/m 2/dag kontinuerligt i 4 dage hver 3. uge (maksimalt 6 serier med platinbaseret behandling og 5-FU) 
• Cetuximab 400 mg/m 2 load then 250 mg/m 2 once weekly, carboplatin AUC 5 mg/mL/min every 3 weeks or cisplatin 100 mg/m 2 every 3 weeks, and 5-FU 1,000 mg/m 2/d 4 days continuous every 3 weeks (maximum of 6 cycles of platinum and 5-FU)
Almindelig hypertyroidisme hypotyroidisme, hypertyroidisme hypofysitis d, tyroiditis e, binyrebarkinsufficiens 
Common hyperthyroidism hypothyroidism, hyperthyroidism hypophysitis d,
Binyrebarkinsufficiens medførte seponering af pembrolizumab hos 4 (0,1%) patienter. 
Adrenal insufficiency led to discontinuation of pembrolizumab in 4 (0.1%) patients.
Medianvarigheden var 1,9 måneder (interval: 1 dag til 25,3+ måneder). 
The median duration was 1.9 months (range 1 day to 25.3+ months).
OS-rate i måned 12, % (95% CI) 
12-month OS rate, % (95% CI)
De hyppigste bivirkninger (rapporteret hos mindst 20% af de pædiatriske patienter) var pyreksi (31%), opkastning (26%), hovedpine (22%), abdominalsmerter (21%), anæmi (21%) og obstipation (20%). 
vomiting (26%), headache (22%), abdominal pain (21%), anaemia (21%) and constipation (20%).
ORR % * Hazard ratio (pembrolizumab kombinationsbehandling sammenlignet med kemoterapi) baseret på den stratificerede Cox proportional hazard-model 
ORR % * Hazard ratio (pembrolizumab combination therapy compared to chemotherapy) based on the stratified Cox proportional hazard model
Pembrolizumab 10 mg/kg hver 3. uge n=181 
Pembrolizumab 10 mg/kg every 3 weeks n=181
Tabel 26: Effektresultater for pembrolizumab plus kemoterapi og pembrolizumab som monoterapi ud fra PD-L1-ekspression i KEYNOTE 048 (CPS ≥ 1 til < 20) 
Table 26: Efficacy results for pembrolizumab plus chemotherapy and pembrolizumab as monotherapy by PD-L1 Expression in KEYNOTE 048 (CPS ≥ 1 to < 20)
Responsvarighed Median i måneder (interval) 
Number of responders Median in months (range)
Pembrolizumab 2 mg/kg hver 3. uge n=180 
Pembrolizumab 2 mg/kg every 3 weeks n=180
og paclitaxel 200 mg/m2 på dag 1 i hver 21-dages serie i 4 serier eller nab-paclitaxel 100 mg/m2 på dag 1, 8 og 15 i hver 21-dages serie i 4 serier, efterfulgt af pembrolizumab 200 mg hver 3. uge. 
• Pembrolizumab 200 mg and carboplatin AUC 6 mg/mL/min on Day 1 of each 21-day cycle for 4 cycles, and paclitaxel 200 mg/m2 on Day 1 of each 21-day cycle for 4 cycles or nab paclitaxel 100 mg/m2 on Days 1, 8 and 15 of each 21-day cycle for 4 cycles, followed by pembrolizumab 200 mg every 3 weeks.
Der blev udført en analyse i KEYNOTE-048 hos patienter, hvis tumorer udtrykte PD-L1 CPS ≥ 20 [pembrolizumab plus kemoterapi: n=126 (49%) versus standardbehandling: n=110 (43%) og pembrolizumab som monoterapi: n=133 (52%) versus standardbehandling: n=122 (48%)] (se tabel 25). 
An analysis was performed in KEYNOTE-048 in patients whose tumours expressed PD-L1 CPS ≥ 20 [pembrolizumab plus chemotherapy: n=126 (49%) vs. standard treatment: n=110 (43%) and pembrolizumab monotherapy: n=133 (52%) vs. standard treatment: n=122 (48%)] (see Table 25).
Tabel 23: Effektresultater for pembrolizumab plus kemoterapi i KEYNOTE-048 med PD-L1ekspression (CPS ≥ 1) 
Table 23: Efficacy results for pembrolizumab plus chemotherapy in KEYNOTE-048 with PDL1 expression (CPS ≥ 1)
Hos patienterne i KEYNOTE-013 var baseline-karakteristika: medianalder 32 år (7% ≥ 65 år), 58% mænd, 94% kaukasere; og 45% og 55% havde henholdsvis ECOG-performance-status 0 og 1. 
Among KEYNOTE-013 patients, the baseline characteristics were median age 32 years (7% age 65 or older), 58% male, 94% White; and 45% and 55% had an ECOG performance status 0 and 1, respectively.
Figur 17: Kaplan-Meier-kurve for progressionsfri overlevelse i hver behandlingsarm i KEYNOTE-426 (intent to treat-population)* 
Figure 17: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-426 (intent to treat population)*
Pembrolizumab + platinbaseret kemoterapi + 5-FU n=242 
Pembrolizumab + Platinum Chemotherapy + 5-FU n=242
Median i måneder (95% CI) 6-måneders OS-rate 12-måneders OS-rate 
Median in months (95% CI) 6-month OS rate 12-month OS rate
KEYNOTE-048: Kontrolleret studie af monoterapi og kombinationsbehandling hos behandlingsnaive HNSCC-patienter i behandling for recidiverende eller metastatisk sygdom Pembrolizumabs virkning blev undersøgt i KEYNOTE-048, et randomiseret, åbent, aktivt kontrolleret multicenterstudie hos patienter med histologisk bekræftet metastatisk eller recidiverende HNSCC i mundhulen, svælget (farynx) eller struben (larynx), som ikke tidligere havde fået systemisk behandling for recidiverende eller metastatisk sygdom, og som blev anset for at være uhelbredeligt med lokal behandling. 
The efficacy of pembrolizumab was investigated in KEYNOTE-048, a multicentre, randomized, open-label, active-controlled study in patients with histologically confirmed metastatic or recurrent HNSCC of the oral cavity, pharynx or larynx, who had not previously received systemic therapy for recurrent or metastatic disease and who were considered incurable by local therapies.
Det rekonstituerede KEYTRUDA-koncentrat er en klar til let opaliserende og farveløs til lysegul opløsning. 
Reconstituted KEYTRUDA is a clear to slightly opalescent, colourless to slightly yellow solution.
Figur 7: Kaplan-Meier-kurve for samlet overlevelse i hver behandlingsarm i KEYNOTE-189 (intent to treat-population) 
Figure 7: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-189 (intent to treat population)
Median i måneder (95% CI) 6-måneders PFS-rate 12-måneders PFS-rate 
Median in months (95% CI) 6-month PFS rate 12-month PFS rate
Virkningsstudie efter tilladelse til markedsføring (PAES): Indehaveren af markedsføringstilladelsen skal indsende den endelige studierapport for studie P407: Et randomiseret, dobbeltblindet fase III-studie af carboplatin - paclitaxel/nabpaclitaxel-kemoterapi med eller uden pembrolizumab (MK-3475) som førstelinjebehandling hos forsøgspersoner med metastatisk planocellulær ikkesmåcellet lungecancer - Endelig studierapport 
Post-authorisation efficacy study (PAES): The MAH should submit the final study report for study P407: A Randomised, Double-Blind, Phase III Study of Carboplatin - Paclitaxel/Nab-Paclitaxel Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Squamous Non-small Cell Lung Cancer Subjects - Final Study Report
Behandlingen kunne fortsætte efter progression, hvis patienten var klinisk stabil, og investigator mente, at patienten havde en klinisk fordel. 
Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator.
Pembrolizumab Placebo 
Pembrolizumab
Figur 8: Kaplan-Meier-kurve for progressionsfri overlevelse i hver behandlingsarm i KEYNOTE-189 (intent to treat-population) 
Figure 8: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-189 (intent to treat population)
Keytruda 50 mg pulver til koncentrat til infusionsvæske, opløsning pembrolizumab 
KEYTRUDA 50 mg powder for concentrate for solution for infusion pembrolizumab
I en subgruppeanalyse viste pembrolizumab en reduceret fordel med hensyn til overlevelse sammenlignet med kemoterapi hos de få patienter, som aldrig havde røget. 
In a subgroup analysis, a reduced survival benefit of pembrolizumab compared to chemotherapy was observed in the small number of patients who were never-smokers; however, due to the small number of patients, no definitive conclusions can be drawn from these data.
Sekundære resultatmål var OS og ORR (baseret på BICR-vurdering i henhold til RECIST 1.1). 
Secondary efficacy outcome measures were OS and ORR (as assessed by BICR using RECIST 1.1).
Pembrolizumab + platinbaseret kemoterapi + 5-FU n=126 
Pembrolizumab + Platinum Chemotherapy + 5-FU n=126
Kemoterapi 
Chemotherapy
Figur 16: Kaplan-Meier-kurve for samlet overlevelse i hver behandlingsarm i KEYNOTE-426 (intent to treat-population)* 
Figure 16: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-426 (intent to treat population)*
Pembrolizumab 10 mg/kg hver 2. uge n=31 
Pembrolizumab 10 mg/kg every 2 weeks n=31
Pembrolizumab + platinbaseret kemoterapi + 5-FU n=116 
Pembrolizumab + Platinum Chemotherapy + 5-FU n=116
KEYTRUDA 25 mg/ml koncentrat til infusionsvæske, opløsning. 
KEYTRUDA 25 mg/mL concentrate for solution for infusion.
Baseret på Miettinen- og Nurminen-metoden stratificeret ud fra PD-L1-status, platinbaseret kemoterapi og rygestatus 
Based on patients with a best overall response as confirmed complete or partial response Based on Miettinen and Nurminen method stratified by PD-L1 status, platinum chemotherapy and smoking status
Behandlingen kunne fortsætte efter sygdomsprogression, hvis patienten var klinisk stabil, og investigator mente, at patienten havde en klinisk fordel. 
Treatment could continue beyond disease progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator.
Hepatitis forekom hos 50 (0,8%) patienter, som fik pembrolizumab, inklusive tilfælde af grad 2, 3 eller 4 hos henholdsvis 8 (0,1%), 31 (0,5%) og 8 (0,1%) patienter. 
Hepatitis occurred in 50 (0.8%) patients, including Grade 2, 3 or 4 cases in 8 (0.1%), 31 (0.5%) and 8 (0.1%) patients, respectively, receiving pembrolizumab.
Antal (% #) patienter med varighed ≥ 6 måneder Antal (% #) patienter med varighed ≥ 12 måneder 
#) of patients with duration ≥ 6 months Number (%
Der er begrænsede data vedrørende sikkerhed fra patienter ≥ 75 år, som har fået adjuverende behandling for melanom. 
Safety data of pembrolizumab in the adjuvant melanoma setting in patients ≥ 75 years are limited.
Tabel 25: Effektresultater for pembrolizumab plus kemoterapi og pembrolizumab som monoterapi ud fra PD-L1-ekspression i KEYNOTE 048 (CPS ≥ 20) 
Table 25: Efficacy results for pembrolizumab plus chemotherapy and pembrolizumab as monotherapy by PD-L1 Expression in KEYNOTE 048 (CPS ≥ 20)
Hjælpestoffer: L-histidin, L-histidin-hydrochloridmonohydrat, saccharose, polysorbat 80. 
Excipients: L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80.
2. kvartal 2021 
2Q 2021
Objektiv responsrate ORR % (95% CI) Komplet remission Partiel remission Responssvarighed Median i måneder (interval) 
Objective response rate ORR % (95% CI) Complete Remission Partial Remission Response duration Median in months (range)
Administration af pembrolizumab og axitinib var tilladt efter sygdomsprogression i henhold til RECIST, hvis patienten var klinisk stabil, og investigator mente, at patienten havde en klinisk fordel. 
Administration of pembrolizumab and axitinib was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered to be deriving clinical benefit by the investigator.
pneumonitis (interstitiel lungesygdom) m. abdominalsmerter (abdominalgener, øvre abdominalsmerter og nedre abdominalsmerter) n. colitis (mikroskopisk colitis, enterocolitis, hæmoragisk enterocolitis og autoimmun colitis) o. pankreatitis (autoimmun pankreatitis og akut pankreatitis) p. hepatitis (autoimmun hepatitis, immunmedieret hepatitis og lægemiddelinduceret leverskade) q. udslæt (erytematøst udslæt, follikulært udslæt, generaliseret udslæt, makuløst udslæt, makulopapuløst udslæt, papuløst udslæt, pruritisk udslæt, vesikuløst udslæt og genitalt udslæt) 
pneumonitis (interstitial lung disease) m. abdominal pain (abdominal discomfort, abdominal pain upper and abdominal pain lower) n. colitis (colitis microscopic, enterocolitis, enterocolitis haemorrhagic, and autoimmune colitis) o. pancreatitis (autoimmune pancreatitis and pancreatitis acute) p. hepatitis (autoimmune hepatitis, immune-mediated hepatitis and drug induced liver injury) q. rash (rash erythematous, rash follicular, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash vesicular and genital rash)
Median i måneder (95% CI) Bedste samlede respons ORR % (95% CI) Komplet respons % Partielt respons % Responsvarighed Median i måneder (interval) 
Median in months (95% CI) Overall response rate ORR % (95% CI) Complete response % Partial response % Response duration Median in months (range)
Sjælden (kan forekomme hos op til 1 ud af 1.000 personer) - nedsat antal hvide blodlegemer (eosinofiler) - inflammation i hjertemusklen, som kan vise sig som kortåndethed, uregelmæssig hjerterytme, 
- a decreased number of white blood cells (eosinophils) - inflammation of the heart muscle, which may present as shortness of breath, irregular heartbeat,
Baseret på patienter med en bedste samlet respons, der er bekræftet komplet eller partielt respons Baseret på Miettinen og Nurminen-metoden stratificeret ud fra IMDC-risikogruppe og geografisk område Baseret på estimering i henhold til Kaplan-Meier 
Based on the stratified Cox proportional hazard model Based on stratified log-rank test Assessed by BICR using RECIST 1.1 Based on patients with a best overall response as confirmed complete or partial response Based on Miettinen and Nurminen method stratified by IMDC risk group and geographic region Based on Kaplan-Meier estimation NA = not available
Binyrebarkinsufficiens forekom hos 46 (0,8%) patienter, som fik pembrolizumab, inklusive tilfælde af grad 2, 3 eller 4 hos henholdsvis 19 (0,3%), 20 (0,3%) og 3 (0,1%) patienter. 
Adrenal insufficiency occurred in 46 (0.8%) patients, including Grade 2, 3 or 4 cases in 19 (0.3%), 20 (0.3%) and 3 (0.1%) patients, respectively, receiving pembrolizumab.
Alvorlige immunrelaterede hudreaktioner er rapporteret hos patienter, der fik pembrolizumab (se pkt. 
Immune-related severe skin reactions have been reported in patients receiving pembrolizumab (see section 4.8).
Farmakoterapeutisk klassifikation: antineoplastiske stoffer, monoklonale antistoffer, ATC-kode: L01XC18 
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies.